Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00006604
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), International Maternal Pediatric Adolescent AIDS Clinical Trials Group (Other)
195
36
9
166
5.4
0
Study Details
Study Description
Brief Summary
The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents.
Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Advancements in HAART for HIV-infected children and adolescents are hindered by patient nonadherence. The availability of a powder formulation and the once-daily dosing schedule make ATV an attractive agent for improved adherence in pediatric treatment regimens. This study was designed to provide pharmacokinetic (PK) data to guide dosing recommendations for ATV, when given concurrently with or without low-dose RTV boost, in infants, children, and adolescents. During the study, the safety and tolerance of ATV (with or without low-dose RTV) were closely monitored, and virologic efficacy data were obtained.
There were two parts to this study. Step I took place in the United States and South Africa, and were further divided into two sets of groups, Parts A and B. Part A participants received ATV only and Part B participants received ATV with low-dose RTV boost. All participants received ATV once a day with 2 other antiretroviral drugs (not provided by the study). In Part B only, participants received ATV with a low dose of RTV. Participants were placed into 1 of 8 groups (Groups 1 to 4 for Part A; Groups 5 to 8 for Part B) with respect to age and study drug formulation. Participants in Groups 1 and 5 were infants between ages 3 months and 1 day (91 days) and 2 years (less than or exactly 730 days) and took ATV in powder form. Participants in Groups 2, 3, 6, and 7 were children between 2 years and 1 day (731 days) old and 13 years old. Groups 2 and 6 received ATV in powder form, while Groups 3 and 7 received the capsule form. Patients in Groups 4 and 8 were adolescents between 13 years and 1 day old and 21 years old (not including the 22nd birthday) and took ATV in capsule form. As of 01/02/2008 a new group, 5A was opened for enrollment. Participants in Group 5A were between 3 months and 6 months old and took ATV in powder form plus a low-dose RTV booster.
For each group, enrollment started with five participants per group. All participants were evaluated for PK and safety criteria, adjusting the dose of ATV until one was found that passes both sets of criteria. Then five additional participants were enrolled, with enrollment continuing for each group once all participants within that group meet the PK criteria. For groups receiving RTV (Groups 5 to 8), additional criteria must be met for each dose of ATV studied. In addition to the PK and safety evaluations, 24-hour post-dose concentrations (Cmin) were monitored in the first 10 participants enrolled for a dose of ATV before more participants were enrolled and studied at that same dose. Note that in Protocol Version 5.0, South African (S.A.) sites were allowed to enroll patients in study groups 3,4,5,6,7,8. As a result, the study design has been modified to further stratify study groups 3, 4, 5, 6, 7, 8 (at the final recommended dose), by country, i.e., U.S.A. versus S.A., such that 10 evaluable study subjects will be accrued in parallel to each study group-country cohort.
Clinic visits will be every 4 weeks through Week 48, then every 8 weeks until the last participant to enroll in the study has reached Week 96 of his/her treatment. If, after 56 weeks, a participant has a toxic reaction to a nucleoside/tide reverse transcriptase inhibitor (NRTI) in their medication regimen, the regimen may be changed to a different NRTI. At every visit, participants will undergo a complete medical history and physical exam, cardiac conduction evaluation, and urine and blood collection. Participants of childbearing age will have a pregnancy test performed at each visit.
Step II will only be open to South African subjects who are virologically responding to treatment when the last enrollee into either part of Step I (Part A or Part B) has completed 96 weeks of treatment (end of Step I) . All such participants will be given ATV in capsule form at the same dose they received at the end of Step I, as well as the other antiretrovirals they were receiving during Step I. Step II will continue until ATV is approved in South Africa and readily available by individual prescription, and participants will have a study visit every 12 weeks.
Note that the following ATV doses were independently evaluated for each group during the dose-finding stage based on the description above: Group 1 ATV Powder (310mg/m2, 620mg/m2); Group 2 ATV Powder (310mg/m2, 620mg/m2); Group 3 ATV Capsule (310mg/m2, 415mg/m2, 520mg/m2); Group 4 ATV Capsule (310mg/m2, 520mg/m2, 620mg/m2); Group 5 ATV Powder + RTV (310mg/m2); Group 6 ATV Powder +RTV (310mg/m2); Group 7 ATV Capsule + RTV (310mg/m2, 205mg/m2); Group 8 ATV Capsule + RTV (310mg/m2, 205mg/m2); Group 5A ATV Powder + RTV (310mg/m^2). All these dosing groups are presented in Participant Flow groups to show the total number of participants enrolled, but only the participants enrolled at the final group doses are presented in the subsequent results.
The following groups satisfied the safety and PK guidelines specified in the protocol: Groups 3,4,6,7,8. Groups 5 and 5A did not satisfy the protocol-defined pharmacokinetic criteria. There was considerable inter-subject variability in systemic exposures in this age group, such that a dose escalation to 415mg/m^2 may have resulted in ATV exposures greater than 90,000 ng*hr/mL in some children. Thus, a further dose increase in Groups 5 and 5A was not attempted.
These are the final dose for each group: Groups 1 and 2 (Final dose was not established); Group 3 ATV Capsule (520mg/m2); Group 4 ATV Capsule (620mg/m2); Group 5 ATV Powder (310mg/m2) + RTV; Group 6 ATV Powder (310mg/m2) +RTV; Group 7 ATV Capsule (205mg/m2) + RTV; Group 8 ATV Capsule (205mg/m2) + RTV; Group 5A ATV Powder (310mg/m^2) + RTV.
Study Design
Study Type:
Interventional
Actual Enrollment
:
195 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II, Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS 232632, Atazanavir, ATV, Reyataz) in Combination Regimens in Antiretroviral Therapy (ART)-Naive and -Experienced HIV-Infected Infants, Children, and Adolescents
Study Start Date
:
Nov 1, 2000
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Step I: Group 1 Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 620 mg/m^2; Final Dose: Not Established |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
|
| Experimental: Step I: Group 2 Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 620 mg/m^2; Final Dose: Not Established |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
|
| Experimental: Step I: Group 3 Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 415 mg/m2, 520 mg/m^2; Final Dose: 520 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
|
| Experimental: Step I: Group 4 Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 520 mg/m^2, 620 mg/m^2; Final Dose: 620 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
|
| Experimental: Step I: Group 5 Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Drug: Ritonavir
Administered as 100 mg capsules or oral solution.
|
| Experimental: Step I: Group 5a Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Drug: Ritonavir
Administered as 100 mg capsules or oral solution.
|
| Experimental: Step I: Group 6 Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Drug: Ritonavir
Administered as 100 mg capsules or oral solution.
|
| Experimental: Step I: Group 7 Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2, 205 mg/m^2; Final Dose: 205 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Drug: Ritonavir
Administered as 100 mg capsules or oral solution.
|
| Experimental: Step I: Group 8 Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2, 205 mg/m^2; Final Dose: 205 mg/m^2 |
Drug: ATV
Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Drug: Ritonavir
Administered as 100 mg capsules or oral solution.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV [From study entry up to week 96]
Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team.
- Number of Participants Who Died [From study entry up to week 96]
- Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h) [Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)]
Pharmacokinetics were determined by non-compartmental analysis and AUC0-24hr calculated by the linear trapezoidal method.
- Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24) [Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)]
Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration.
- Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) [Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)]
Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually.
- Pharmacokinetic (PK) Parameter: Clearance (CL/F) [Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)]
Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0-24hr.
Secondary Outcome Measures
- Percentage of Participants With HIV RNA <400 Copies/mL at Week 24 [Week 24]
Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.
- Percentage of Participants With HIV RNA <400 Copies/mL at Week 48 [Week 48]
Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.
- Percentage of Participants With HIV RNA <400 Copies/mL at Week 96 [Week 96]
Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.
- Change in CD4 Count (Cells/mm^3) From Baseline to Week 20 [Baseline, Week 20]
- Change in CD4 Count (Cells/mm^3) From Baseline to Week 48 [Baseline, Week 48]
- Change in CD4 Count (Cells/mm^3) From Baseline to Week 96 [Baseline, Week 96]
- Change in CD4 Percent From Baseline to Week 20 [Baseline, Week 20]
- Change in CD4 Percent From Baseline to Week 48 [Baseline, Week 48]
- Change in CD4 Percent From Baseline to Week 96 [Baseline, Week 96]
Eligibility Criteria
Criteria
Ages Eligible for Study:
91 Days
to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria for Step I:
-
Age: 91 days to 21 years of age (not including the 22nd birthday).
-
A confirmed diagnosis of HIV infection defined by the current definition of the IMPAACT Virology Core Laboratory Committee. More information about this criterion can be found in the protocol.
-
Viral load greater than or equal to 5,000 copies/mL
-
Any CDC clinical classification and immune status
-
Antiretroviral treatment-naïve or -experienced study candidates must be able to add two new NRTIs as part of their new therapy in this protocol, or have genotypic evidence of sensitivity to two NRTIs (the NRTIs must be used in combinations recommended in the Guidelines for the Use of Antiretroviral Agents in Pediatric and Adolescent HIV Infection). More information about this criterion can be found in the protocol.
-
Study candidates must show evidence of retained phenotypic sensitivity to ATV (resistance index ratio of less than 10) when the subject has failed (after at least 12 weeks of therapy) two or more courses of PI containing regimens. More information about this criterion can be found in the protocol.
-
Demonstrated ability and willingness to swallow study medications
-
Study candidate, parent, or legal guardian must be able and willing to provide signed informed consent
-
Female participants who are sexually active and able to become pregnant must use two methods of birth control. More information about this criterion can be found in the protocol.
-
Males participating in the study must not attempt to impregnate a female, or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom.
-
Study candidates with a history of undefined syncope will require a complete cardiac conduction evaluation at screening [e.g., ECG, 24-hour monitoring (Holter), and exercise test (if age appropriate)]. This evaluation must rule-out any cardiac conduction abnormalities.
Exclusion Criteria for Step I:
-
Active hepatitis
-
Presence of an acute serious/invasive infection requiring therapy at the time of enrollment
-
Hypersensitivity to any component of the formulation of ATV
-
Chemotherapy for active malignancy
-
Pregnant or breastfeeding
-
Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the clinician's opinion, would compromise the outcome of this study
-
Any laboratory or clinical toxicity greater than Grade 2 at entry
-
Documented history of cardiac conduction abnormalities or significant cardiac dysfunction
-
History of undefined syncope that cannot be ruled out as related to cardiac conduction abnormalities
-
Family history of prolonged QTc-interval syndrome, Brugada syndrome, or right-ventricular (RV) dysplasia
-
Corrected QTc-Interval greater than 440 msec at screening
-
Prolonged PR-Interval greater than 0.200 seconds (200 ms) on ECG at screening (study candidates greater than or equal to 13 years of age)
-
PR-Interval greater than 98th percentile on ECG at screening (study candidates less than 13 years of age)
-
Cardiac rhythm abnormalities:
-
A type I second-degree atrioventricular (AV) block (Mobitz type I heart-block) occurring during waking hours on ECG at screening
-
A type II second-degree AV-block (Mobitz type II heart-block) at any time on ECG at screening
-
A complete AV-block at any time on ECG at screening
-
A heart rate less than the 2nd percentile for age of the normal heart rate range on ECG at screening
- Prolonged therapy with intravenous pentamidine for acute Pneumocystis Carinii Pneumonia (PCP) within three months of entry
Inclusion Criteria for Step II:
-
Any South African subject enrolled into either part of Step I, who is virologically successful by Week 96 of when the last study participant enrolled into the respective part of Step I
-
Female participants who are sexually active and able to become pregnant must continue using two methods of birth control. More information about this criterion can be found in the protocol.
-
Males who continue participation in the study must not attempt to impregnate a woman, or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom.
Exclusion Criteria for Step II:
-
A South African participant who meets any of the criteria for treatment discontinuation by Week 96 of when the last participant enrolled into either part of Step I
-
A South African participant who meets any of the exclusion criteria from Step I by Week 96 of when the last participant enrolled into either part of Step I
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB Pediatric Infectious Diseases CRS | Birmingham | Alabama | United States | 35233 |
| 2 | Usc La Nichd Crs | Alhambra | California | United States | 91803 |
| 3 | University of California, UC San Diego CRS | La Jolla | California | United States | 92093-0672 |
| 4 | Miller Children's Hosp. Long Beach CA NICHD CRS | Long Beach | California | United States | 90806 |
| 5 | UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | United States | 900951752 |
| 6 | Univ. of California San Francisco NICHD CRS | San Francisco | California | United States | 94143 |
| 7 | Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | United States | 80045 |
| 8 | Howard Univ. Washington DC NICHD CRS | Washington | District of Columbia | United States | 20060 |
| 9 | South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | United States | 33316 |
| 10 | Columbus Regional HealthCare System, The Med. Ctr. | Columbus | Georgia | United States | 31901 |
| 11 | Rush Univ. Cook County Hosp. Chicago NICHD CRS | Chicago | Illinois | United States | 60612 |
| 12 | Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS | Chicago | Illinois | United States | 60614 |
| 13 | Tulane Univ. New Orleans NICHD CRS | New Orleans | Louisiana | United States | 701122699 |
| 14 | Univ. of Maryland Baltimore NICHD CRS | Baltimore | Maryland | United States | 21201 |
| 15 | Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | United States | 21287 |
| 16 | Boston Medical Center Ped. HIV Program NICHD CRS | Boston | Massachusetts | United States | 02118 |
| 17 | WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | United States | 016550001 |
| 18 | Rutgers - New Jersey Medical School CRS | Newark | New Jersey | United States | 07103 |
| 19 | Bronx-Lebanon Hospital Center NICHD CRS | Bronx | New York | United States | 10457 |
| 20 | Jacobi Med. Ctr. Bronx NICHD CRS | Bronx | New York | United States | 10461 |
| 21 | Nyu Ny Nichd Crs | New York | New York | United States | 10016 |
| 22 | Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | United States | 10037 |
| 23 | SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | United States | 13210 |
| 24 | DUMC Ped. CRS | Durham | North Carolina | United States | 277103499 |
| 25 | Philadelphia IMPAACT Unit CRS | Philadelphia | Pennsylvania | United States | 19104 |
| 26 | St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | United States | 191341095 |
| 27 | St. Jude Children's Research Hospital CRS | Memphis | Tennessee | United States | 38105 |
| 28 | Children's Med. Ctr. Dallas | Dallas | Texas | United States | 75235 |
| 29 | Texas Children's Hospital CRS | Houston | Texas | United States | 77030 |
| 30 | Children's Hosp. of the King's Daughters, Infectious Disease | Norfolk | Virginia | United States | 23507 |
| 31 | Childrens Hosp. of the Kings Daughters | Norfolk | Virginia | United States | 23507 |
| 32 | Seattle Children's Research Institute CRS | Seattle | Washington | United States | 98105 |
| 33 | Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. | Bayamon | Puerto Rico | 00956 | |
| 34 | San Juan City Hosp. PR NICHD CRS | San Juan | Puerto Rico | 00936 | |
| 35 | Soweto IMPAACT CRS | Johannesburg | Gauteng | South Africa | 1864 |
| 36 | Shandukani CRS | Johannesburg | Gauteng | South Africa | 2001 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
- Study Chair: Richard Rutstein, MD, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Aldrovandi G, Samson P, Fenton T, Schnittman S, and Rutstein R for the P1020A Team. Genotypic and phenotypic resistance to BMS232632 (Atazanavir-ATV), among heavily experienced pediatric patients who were ATV-naïve. 9th Conference on Retroviruses and Opportunistic Infections, February 24 - 28, 2002, Seattle, WA.
- Aldrovandi G, Samson P, Fenton T, Schnittman S, Rutstein R, Ortiz A and the Pediatric AIDS Clinical Trial 1020A Group. Resistance to Atazanavir (ATV), Lopinavir (LPV), Tenofovir (TFV) Among Heavily Experienced Pediatric Patients. 12th International Symposium on HIV and Emerging Infectious Diseases in Toulon, France, June 2002.
- Kiser J, Rutstein R, Aldrovandi G, Samson P, Graham B, Schnittman S, Smith M, Mofenson L, Fletcher C, and the PACTG 1020A Study Team. Pharmacokinetics of atazanavir/ritonavir in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2005.
- Kiser J, Rutstein R, Samson P, Graham B, Aldrovandi G, Mofenson L, Smith E, Zhang J, Biguenet S, Fletcher C, and the P1020A team. Atazanavir dosing conversion and pharmacokinetics in HIV-infected children switching from atazanavir powder to capsules. 12 th International Workshop on Clinical Pharmacology of HIV Therapy, Miami, Florida, April 2011.
- Kiser JJ, Rutstein RM, Samson P, Graham B, Aldrovandi G, Mofenson LM, Smith E, Schnittman S, Fenton T, Brundage RC, Fletcher CV. Atazanavir and atazanavir/ritonavir pharmacokinetics in HIV-infected infants, children, and adolescents. AIDS. 2011 Jul 31;25(12):1489-96. doi: 10.1097/QAD.0b013e328348fc41.
- Meyers T, Rutstein R, Samson P, Violari A, Palmer M, Kiser J, Fletcher C, Fenton T, Mofenson L, Graham B, Schnittman S, Horga M, Aldrovandi G, for the PACTG 1020A Study. Treatment responses to atazanavir-containing HAART in a drug-naïve pediatric population in South Africa. 15th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2008.
- Rutstein R, Samson P, Aldrovandi G, Graham B, Schnittman S, Fletcher C, Kiser J, Smith E, Mofenson L, Fenton T, and the PACTG 1020A Study Team. Effect of atazanavir on serum cholesterol and triglyceride levels in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2005.
- Rutstein R, Samson P, Fenton T, Kiser J, Fletcher C, Schnittman S, Mofenson L, Smith E, Graham B, Aldrovandi G, PACTG 1020A Study. The NIH PACTG Protocol 1020A: ATAZANAVIR (ATV), +/- RITONAVIR in HIV-Infected Infants, Children and Adolescents. Presented at the 14th Conference on Retrovirus and Opportunistic Infection (CROI), Los Angeles, CA, February, 2007.
- Rutstein RM, Samson P, Fenton T, Fletcher CV, Kiser JJ, Mofenson LM, Smith E, Graham B, Mathew M, Aldrovani G; PACTG 1020A Study Team. Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children and adolescents: the Pediatric AIDS Clinical Trials Group Protocol 1020A. Pediatr Infect Dis J. 2015 Feb;34(2):162-7. doi: 10.1097/INF.0000000000000538.
- Samson P, Rutstein R, Fenton T, Kiser J, Fletcher C, Schnittman S, Mofenson L, Smith E, Graham B, Aldrovandi G, and the PACTG 1020A Study Team. Changes in cholesterol and triglyceride levels among pediatric subjects treated with atazanavir, with or without ritonavir boosting: the 1020A NIH PACTG protocol. 13th Conference on Retroviruses and Opportunistic Infections, Denver, CO, February 2006.
- Samson P, Rutstein R, Schnittman S, Ortiz A, Graham B, Fenton T, Aldrovandi G and the Pediatric AIDS Clinical Trials Group P1020A Study Team. Effects of Antiretroviral (ARV) Exposure and Genotypic (Geno) Mutations in Predicting Phenotypic Resistance (PRS) to Atazanavir (ATV), Lopinavir (LPV), and Tenofovir (TDF) in Patients Naïve to these Drugs. 13th International Symposium on HIV and Emerging Infectious Diseases, Toulon, France, June 2004.
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006604
Other Study ID Numbers:
- P1020A
- 10037
- IMPAACT P1020A
- PACTG P1020-A
- ACTG P1020-A
First Posted:
Aug 31, 2001
Last Update Posted:
Nov 5, 2021
Last Verified:
Mar 1, 2016
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Date of First Enrollment: 16 November 2000; Date of Last Enrollment: 22 December 2009 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: ATV Dose: Powder (310mg/m^2) | Group 1: ATV Dose: Powder (620mg/m^2) | Group 2: ATV Powder (310mg/m^2) | Group 2: ATV Powder (620mg/m^2) | Group 3: ATV Capsule (310mg/m^2) | Group 3: ATV Capsule (415mg/m^2) | Group 3: ATV Capsule (520mg/m^2) | Group 4: ATV Capsule (310mg/m^2) | Group 4: ATV Capsule (520mg/m^2) | Group 4: ATV Capsule (620mg/m^2) | Group 5: ATV Powder (310mg/m^2) + RTV | Group 5a: ATV Powder (310mg/m^2) + RTV | Group 6: ATV Powder (310mg/m^2) + RTV | Group 7: ATV Capsule (310mg/m^2) + RTV | Group 7: ATV Capsule (205mg/m^2) + RTV | Group 8: ATV Capsule (310mg/m^2) + RTV | Group 8: ATV Capsule (205mg/m^2) + RTV |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. | Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. | Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. | Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs. | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. Note: This is the final recommended dose for this group. | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. Note: This is the final recommended dose for this group. | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. |
| Period Title: Overall Study | |||||||||||||||||
| STARTED | 6 | 2 | 5 | 6 | 5 | 5 | 21 | 5 | 5 | 25 | 21 | 12 | 26 | 6 | 24 | 6 | 15 |
| COMPLETED | 4 | 2 | 1 | 1 | 3 | 2 | 12 | 2 | 4 | 6 | 13 | 6 | 22 | 0 | 14 | 1 | 6 |
| NOT COMPLETED | 2 | 0 | 4 | 5 | 2 | 3 | 9 | 3 | 1 | 19 | 8 | 6 | 4 | 6 | 10 | 5 | 9 |
Baseline Characteristics
| Arm/Group Title | Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule) | Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule) | Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV) | Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV) | Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV) | Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV) | Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV) | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Total of all reporting groups |
| Overall Participants | 21 | 25 | 21 | 11 | 26 | 24 | 14 | 142 |
| Age (years) [Median (Full Range) ] | ||||||||
| Median (Full Range) [years] |
8.6
|
14.3
|
1.2
|
0.4
|
4.4
|
9
|
17
|
7
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
11
52.4%
|
18
72%
|
8
38.1%
|
6
54.5%
|
12
46.2%
|
11
45.8%
|
9
64.3%
|
75
52.8%
|
| Male |
10
47.6%
|
7
28%
|
13
61.9%
|
5
45.5%
|
14
53.8%
|
13
54.2%
|
5
35.7%
|
67
47.2%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||||
| White Non-Hispanic |
4
19%
|
0
0%
|
0
0%
|
0
0%
|
1
3.8%
|
0
0%
|
0
0%
|
5
3.5%
|
| Black Non-Hispanic |
14
66.7%
|
17
68%
|
18
85.7%
|
10
90.9%
|
18
69.2%
|
17
70.8%
|
8
57.1%
|
102
71.8%
|
| Hisp-Regardless of Race |
3
14.3%
|
7
28%
|
2
9.5%
|
1
9.1%
|
7
26.9%
|
5
20.8%
|
5
35.7%
|
30
21.1%
|
| More than one race |
0
0%
|
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
1
4.2%
|
1
7.1%
|
3
2.1%
|
| Unavailable |
0
0%
|
1
4%
|
0
0%
|
0
0%
|
0
0%
|
1
4.2%
|
0
0%
|
2
1.4%
|
| CD4 Count (cells/mm^3) [Median (Full Range) ] | ||||||||
| Median (Full Range) [cells/mm^3] |
374
|
286
|
1306
|
2125
|
466
|
540
|
334
|
457
|
| CD4 Percent (percentage of total lymphocytes) [Median (Full Range) ] | ||||||||
| Median (Full Range) [percentage of total lymphocytes] |
18
|
14
|
19
|
35
|
16
|
21
|
19
|
18
|
| HIV-RNA (log10 copies/ml) [Median (Full Range) ] | ||||||||
| Median (Full Range) [log10 copies/ml] |
4.4
|
4.7
|
5
|
5
|
4.8
|
4.5
|
4.3
|
4.8
|
Outcome Measures
| Title | Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV |
|---|---|
| Description | Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team. |
| Time Frame | From study entry up to week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients accrued at the final recommended dose for each group. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 21 | 25 | 21 | 11 | 26 | 24 | 14 |
| Total Bilirubin >= 5.1xULN |
1
4.8%
|
4
16%
|
0
0%
|
0
0%
|
0
0%
|
4
16.7%
|
4
28.6%
|
| Increase in PR Interval-Grade 1 |
11
52.4%
|
4
16%
|
3
14.3%
|
1
9.1%
|
4
15.4%
|
5
20.8%
|
1
7.1%
|
| Increase in PR Interval-Grade 2 |
1
4.8%
|
1
4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Heart Rate-Grade 2 |
2
9.5%
|
1
4%
|
3
14.3%
|
1
9.1%
|
1
3.8%
|
4
16.7%
|
0
0%
|
| Heart Rate-Grade 3 |
1
4.8%
|
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Increase in QTc Interval-Grade 3 |
1
4.8%
|
0
0%
|
0
0%
|
1
9.1%
|
1
3.8%
|
0
0%
|
0
0%
|
| Other Grade 3+ Toxicities |
0
0%
|
3
12%
|
0
0%
|
2
18.2%
|
0
0%
|
1
4.2%
|
0
0%
|
| Title | Number of Participants Who Died |
|---|---|
| Description | |
| Time Frame | From study entry up to week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants accrued at the final recommended dose for each group. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 21 | 25 | 21 | 11 | 26 | 24 | 14 |
| Death not attributed to ATV |
0
0%
|
1
4%
|
1
4.8%
|
1
9.1%
|
0
0%
|
0
0%
|
0
0%
|
| Death attributed to ATV |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With HIV RNA <400 Copies/mL at Week 24 |
|---|---|
| Description | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data). Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an 'intent-to-treat' (ITT) approach, in which children who discontinued study treatment for any reason were considered failures. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 21 | 25 | 21 | 9 | 26 | 24 | 13 |
| Number (95% Confidence Interval) [percentage of participants] |
67
319%
|
44
176%
|
57
271.4%
|
44
400%
|
85
326.9%
|
67
279.2%
|
38
271.4%
|
| Title | Percentage of Participants With HIV RNA <400 Copies/mL at Week 48 |
|---|---|
| Description | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data). Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an 'intent-to-treat' (ITT) approach, in which children who discontinued study treatment for any reason were considered failures. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 21 | 25 | 21 | 11 | 26 | 24 | 14 |
| Number (95% Confidence Interval) [percentage of participants] |
62
295.2%
|
32
128%
|
71
338.1%
|
55
500%
|
85
326.9%
|
63
262.5%
|
29
207.1%
|
| Title | Percentage of Participants With HIV RNA <400 Copies/mL at Week 96 |
|---|---|
| Description | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. |
| Time Frame | Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data). Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an 'intent-to-treat' (ITT) approach, in which children who discontinued study treatment for any reason were considered failures. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 21 | 25 | 20 | 5 | 26 | 24 | 14 |
| Number (95% Confidence Interval) [percentage of participants] |
48
228.6%
|
20
80%
|
75
357.1%
|
20
181.8%
|
73
280.8%
|
63
262.5%
|
14
100%
|
| Title | Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h) |
|---|---|
| Description | Pharmacokinetics were determined by non-compartmental analysis and AUC0-24hr calculated by the linear trapezoidal method. |
| Time Frame | Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 20 | 21 | 17 | 11 | 21 | 21 | 14 |
| Median (Inter-Quartile Range) [ng*hr/mL] |
40653
|
51781
|
44243
|
38928
|
52199
|
45680
|
42835
|
| Title | Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24) |
|---|---|
| Description | Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration. |
| Time Frame | Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 20 | 21 | 17 | 11 | 21 | 21 | 14 |
| Median (Inter-Quartile Range) [ng/mL] |
173
|
510
|
482
|
596
|
947
|
575
|
885
|
| Title | Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) |
|---|---|
| Description | Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually. |
| Time Frame | Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. |
| Arm/Group Title | Step I: Group 3: ATV Dose 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 Capsule | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 20 | 21 | 17 | 11 | 21 | 21 | 14 |
| Median (Inter-Quartile Range) [ng/mL] |
6463
|
7006
|
6501
|
4952
|
5593
|
5013
|
4095
|
| Title | Pharmacokinetic (PK) Parameter: Clearance (CL/F) |
|---|---|
| Description | Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0-24hr. |
| Time Frame | Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 20 | 21 | 17 | 11 | 21 | 21 | 14 |
| Median (Inter-Quartile Range) [L/hr/m^2] |
12.8
|
11.4
|
7.9
|
8.3
|
5.3
|
4.7
|
4.8
|
| Title | Change in CD4 Count (Cells/mm^3) From Baseline to Week 20 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants accrued at the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 19 | 17 | 17 | 7 | 24 | 21 | 9 |
| Median (Full Range) [Cells/mm^3] |
120
|
184
|
286
|
-294
|
312
|
176
|
139
|
| Title | Change in CD4 Count (Cells/mm^3) From Baseline to Week 48 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 15 | 10 | 14 | 6 | 23 | 20 | 8 |
| Median (Full Range) [Cells/mm^3] |
164
|
140
|
74
|
-232
|
324
|
157
|
135
|
| Title | Change in CD4 Count (Cells/mm^3) From Baseline to Week 96 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 16 | 10 | 14 | 2 | 21 | 17 | 3 |
| Median (Full Range) [cells/mm^3] |
366
|
233
|
340
|
-600
|
317
|
260
|
293
|
| Title | Change in CD4 Percent From Baseline to Week 20 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 19 | 17 | 17 | 7 | 24 | 22 | 9 |
| Median (Full Range) [percentage of total lymphocytes] |
8
|
6
|
8
|
6
|
11
|
7
|
3
|
| Title | Change in CD4 Percent From Baseline to Week 48 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 15 | 10 | 14 | 6 | 23 | 20 | 8 |
| Median (Full Range) [percentage of total lymphocytes] |
7
|
9
|
10
|
0
|
12
|
8
|
5
|
| Title | Change in CD4 Percent From Baseline to Week 96 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. |
| Arm/Group Title | Step I: Group 3: ATV Dose: 520mg/m^2 Capsule | Step I: Group 4: ATV Dose: 620mg/m^2 Capsule | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| Measure Participants | 16 | 10 | 14 | 2 | 21 | 17 | 3 |
| Median (Full Range) [percentage of total lymphocytes] |
14
|
9
|
10
|
-0.5
|
15
|
10
|
9
|
Adverse Events
| Time Frame | From first study enrollment (16 November 2000) up to the last off-study visit (15 September 2014) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | P1020A followed intensive reporting requirements defined in DAIDS Serious Adverse Experience Reporting Manual. AEs graded according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-Threatening, Gr 5=Death. | |||||||||||||
| Arm/Group Title | Group 3: ATV 520mg/m^2 Capsule | Group 4: ATV 620mg/m^2 Capsule | Group 5: ATV 310mg/m^2 Powder + RTV | Group 6: ATV 310mg/m^2 Powder + RTV | Group 7: ATV 205mg/m^2 Capsule + RTV | Group 8: ATV 205mg/m^2 Capsule + RTV | Group 5A: ATV 310mg/m^2 Powder + RTV | |||||||
| Arm/Group Description | 2 years and 1 day (731 days or more) to 13 years of age. ATV capsule + 2 NRTIs Note: This is the final recommended dose for this group. | 13 years and 1 day to 21 (not including the 22nd birthday) years of age. ATV capsule + 2 NRTIs Note: This is the final recommended dose for this group. | 91 days to 2 years of age (less than or exactly 730 days. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 2 years and 1 day (731 days or more) to 13 years of age. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 2 years and 1 day (731 days or more) to 13 years of age. ATV capsule + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 13 years and 1 day to 21 (not including the 22nd birthday) years of age. ATV capsule + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 91 to 180 days of age. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | |||||||
All Cause Mortality |
||||||||||||||
| Group 3: ATV 520mg/m^2 Capsule | Group 4: ATV 620mg/m^2 Capsule | Group 5: ATV 310mg/m^2 Powder + RTV | Group 6: ATV 310mg/m^2 Powder + RTV | Group 7: ATV 205mg/m^2 Capsule + RTV | Group 8: ATV 205mg/m^2 Capsule + RTV | Group 5A: ATV 310mg/m^2 Powder + RTV | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Group 3: ATV 520mg/m^2 Capsule | Group 4: ATV 620mg/m^2 Capsule | Group 5: ATV 310mg/m^2 Powder + RTV | Group 6: ATV 310mg/m^2 Powder + RTV | Group 7: ATV 205mg/m^2 Capsule + RTV | Group 8: ATV 205mg/m^2 Capsule + RTV | Group 5A: ATV 310mg/m^2 Powder + RTV | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/21 (47.6%) | 15/25 (60%) | 12/21 (57.1%) | 14/26 (53.8%) | 15/24 (62.5%) | 8/14 (57.1%) | 5/11 (45.5%) | |||||||
| Cardiac disorders | ||||||||||||||
| Atrioventricular block second degree | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Cardiac failure congestive | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Cardiomyopathy | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Pancreatitis acute | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Hyperbilirubinaemia | 3/21 (14.3%) | 6/25 (24%) | 2/21 (9.5%) | 4/26 (15.4%) | 3/24 (12.5%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Infections and infestations | ||||||||||||||
| Meningitis | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Pneumonia | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Investigations | ||||||||||||||
| Aspartate aminotransferase increased | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Bilirubin conjugated increased | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Blood alkaline phosphatase increased | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Blood bilirubin increased | 7/21 (33.3%) | 8/25 (32%) | 6/21 (28.6%) | 8/26 (30.8%) | 10/24 (41.7%) | 5/14 (35.7%) | 0/11 (0%) | |||||||
| Blood bilirubin unconjugated increased | 1/21 (4.8%) | 6/25 (24%) | 5/21 (23.8%) | 8/26 (30.8%) | 9/24 (37.5%) | 2/14 (14.3%) | 0/11 (0%) | |||||||
| Blood sodium decreased | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Electrocardiogram QT prolonged | 1/21 (4.8%) | 1/25 (4%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Gamma-glutamyltransferase increased | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Lipase increased | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Liver function test abnormal | 0/21 (0%) | 1/25 (4%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Neutrophil count decreased | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Hyponatraemia | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Hodgkin's disease | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||
| Abortion spontaneous | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Glycosuria | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Facial wasting | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Lipoatrophy | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Rash | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Group 3: ATV 520mg/m^2 Capsule | Group 4: ATV 620mg/m^2 Capsule | Group 5: ATV 310mg/m^2 Powder + RTV | Group 6: ATV 310mg/m^2 Powder + RTV | Group 7: ATV 205mg/m^2 Capsule + RTV | Group 8: ATV 205mg/m^2 Capsule + RTV | Group 5A: ATV 310mg/m^2 Powder + RTV | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/21 (100%) | 25/25 (100%) | 21/21 (100%) | 26/26 (100%) | 24/24 (100%) | 14/14 (100%) | 11/11 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Iron deficiency anaemia | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Lymph node pain | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Lymphadenitis | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Lymphadenopathy | 7/21 (33.3%) | 10/25 (40%) | 11/21 (52.4%) | 7/26 (26.9%) | 7/24 (29.2%) | 1/14 (7.1%) | 6/11 (54.5%) | |||||||
| Splenomegaly | 2/21 (9.5%) | 1/25 (4%) | 6/21 (28.6%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Cardiac disorders | ||||||||||||||
| Tachycardia | 0/21 (0%) | 0/25 (0%) | 4/21 (19%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Ear pain | 7/21 (33.3%) | 3/25 (12%) | 4/21 (19%) | 8/26 (30.8%) | 2/24 (8.3%) | 2/14 (14.3%) | 2/11 (18.2%) | |||||||
| Hypoacusis | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Middle ear effusion | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Otorrhoea | 3/21 (14.3%) | 2/25 (8%) | 7/21 (33.3%) | 4/26 (15.4%) | 3/24 (12.5%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Eye disorders | ||||||||||||||
| Conjunctival hyperaemia | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Eye discharge | 5/21 (23.8%) | 0/25 (0%) | 5/21 (23.8%) | 10/26 (38.5%) | 2/24 (8.3%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Eye pain | 0/21 (0%) | 3/25 (12%) | 3/21 (14.3%) | 3/26 (11.5%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Eye pruritus | 3/21 (14.3%) | 2/25 (8%) | 4/21 (19%) | 4/26 (15.4%) | 4/24 (16.7%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Eye swelling | 1/21 (4.8%) | 0/25 (0%) | 3/21 (14.3%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Eyelid oedema | 0/21 (0%) | 0/25 (0%) | 3/21 (14.3%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Ocular hyperaemia | 2/21 (9.5%) | 2/25 (8%) | 2/21 (9.5%) | 6/26 (23.1%) | 5/24 (20.8%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Ocular icterus | 7/21 (33.3%) | 7/25 (28%) | 5/21 (23.8%) | 7/26 (26.9%) | 9/24 (37.5%) | 3/14 (21.4%) | 1/11 (9.1%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal discomfort | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Abdominal distension | 0/21 (0%) | 1/25 (4%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Abdominal pain | 6/21 (28.6%) | 6/25 (24%) | 5/21 (23.8%) | 5/26 (19.2%) | 6/24 (25%) | 2/14 (14.3%) | 0/11 (0%) | |||||||
| Abdominal pain lower | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Abdominal pain upper | 6/21 (28.6%) | 5/25 (20%) | 2/21 (9.5%) | 4/26 (15.4%) | 4/24 (16.7%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Abdominal tenderness | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Constipation | 0/21 (0%) | 1/25 (4%) | 1/21 (4.8%) | 2/26 (7.7%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Diarrhoea | 7/21 (33.3%) | 5/25 (20%) | 12/21 (57.1%) | 11/26 (42.3%) | 7/24 (29.2%) | 4/14 (28.6%) | 8/11 (72.7%) | |||||||
| Dysphagia | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Gastritis | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Gingival ulceration | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Lip ulceration | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Mouth ulceration | 2/21 (9.5%) | 2/25 (8%) | 2/21 (9.5%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Nausea | 4/21 (19%) | 5/25 (20%) | 1/21 (4.8%) | 7/26 (26.9%) | 2/24 (8.3%) | 3/14 (21.4%) | 0/11 (0%) | |||||||
| Oral disorder | 0/21 (0%) | 3/25 (12%) | 4/21 (19%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Proctalgia | 1/21 (4.8%) | 1/25 (4%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Rectal fissure | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Rectal haemorrhage | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Rectal lesion | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Stomatitis | 0/21 (0%) | 1/25 (4%) | 2/21 (9.5%) | 2/26 (7.7%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Toothache | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 5/26 (19.2%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Vomiting | 13/21 (61.9%) | 8/25 (32%) | 14/21 (66.7%) | 19/26 (73.1%) | 7/24 (29.2%) | 3/14 (21.4%) | 5/11 (45.5%) | |||||||
| General disorders | ||||||||||||||
| Asthenia | 0/21 (0%) | 3/25 (12%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Chest pain | 4/21 (19%) | 6/25 (24%) | 2/21 (9.5%) | 4/26 (15.4%) | 6/24 (25%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Chills | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Face oedema | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Facial pain | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Fatigue | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 1/26 (3.8%) | 0/24 (0%) | 3/14 (21.4%) | 1/11 (9.1%) | |||||||
| Pain | 3/21 (14.3%) | 0/25 (0%) | 0/21 (0%) | 2/26 (7.7%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Peripheral swelling | 2/21 (9.5%) | 3/25 (12%) | 1/21 (4.8%) | 1/26 (3.8%) | 5/24 (20.8%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Pyrexia | 14/21 (66.7%) | 8/25 (32%) | 15/21 (71.4%) | 16/26 (61.5%) | 9/24 (37.5%) | 6/14 (42.9%) | 8/11 (72.7%) | |||||||
| Secretion discharge | 3/21 (14.3%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Hepatomegaly | 0/21 (0%) | 4/25 (16%) | 6/21 (28.6%) | 8/26 (30.8%) | 4/24 (16.7%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Jaundice | 2/21 (9.5%) | 3/25 (12%) | 2/21 (9.5%) | 1/26 (3.8%) | 2/24 (8.3%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Immune system disorders | ||||||||||||||
| Immune reconstitution inflammatory syndrome | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Serum sickness | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Acarodermatitis | 3/21 (14.3%) | 2/25 (8%) | 8/21 (38.1%) | 5/26 (19.2%) | 5/24 (20.8%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Acute sinusitis | 2/21 (9.5%) | 3/25 (12%) | 1/21 (4.8%) | 2/26 (7.7%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Body tinea | 1/21 (4.8%) | 0/25 (0%) | 6/21 (28.6%) | 3/26 (11.5%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Bronchiolitis | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Bronchitis | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 6/26 (23.1%) | 1/24 (4.2%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Cellulitis | 2/21 (9.5%) | 2/25 (8%) | 2/21 (9.5%) | 2/26 (7.7%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Conjunctivitis | 6/21 (28.6%) | 0/25 (0%) | 4/21 (19%) | 6/26 (23.1%) | 5/24 (20.8%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Fungal skin infection | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Gastroenteritis | 1/21 (4.8%) | 2/25 (8%) | 5/21 (23.8%) | 4/26 (15.4%) | 2/24 (8.3%) | 2/14 (14.3%) | 5/11 (45.5%) | |||||||
| Gingivitis | 1/21 (4.8%) | 1/25 (4%) | 2/21 (9.5%) | 1/26 (3.8%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Helminthic infection | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Hepatitis A | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Herpes zoster | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Immune reconstitution inflammatory syndrome associated tuberculosis | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Impetigo | 3/21 (14.3%) | 2/25 (8%) | 4/21 (19%) | 5/26 (19.2%) | 4/24 (16.7%) | 0/14 (0%) | 4/11 (36.4%) | |||||||
| Influenza | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Lower respiratory tract infection | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Meningitis haemophilus | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Molluscum contagiosum | 2/21 (9.5%) | 1/25 (4%) | 3/21 (14.3%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Oesophageal candidiasis | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Oral candidiasis | 2/21 (9.5%) | 5/25 (20%) | 4/21 (19%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Oral herpes | 1/21 (4.8%) | 3/25 (12%) | 2/21 (9.5%) | 4/26 (15.4%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Otitis externa | 0/21 (0%) | 2/25 (8%) | 2/21 (9.5%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Otitis media | 7/21 (33.3%) | 3/25 (12%) | 8/21 (38.1%) | 9/26 (34.6%) | 2/24 (8.3%) | 2/14 (14.3%) | 3/11 (27.3%) | |||||||
| Otitis media acute | 2/21 (9.5%) | 3/25 (12%) | 11/21 (52.4%) | 5/26 (19.2%) | 3/24 (12.5%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Otitis media chronic | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Parotitis | 1/21 (4.8%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Pharyngitis | 4/21 (19%) | 5/25 (20%) | 7/21 (33.3%) | 10/26 (38.5%) | 6/24 (25%) | 1/14 (7.1%) | 3/11 (27.3%) | |||||||
| Pharyngitis streptococcal | 4/21 (19%) | 0/25 (0%) | 1/21 (4.8%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Pneumonia | 5/21 (23.8%) | 3/25 (12%) | 8/21 (38.1%) | 6/26 (23.1%) | 7/24 (29.2%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Pneumonia bacterial | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 1/26 (3.8%) | 1/24 (4.2%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Pneumonia viral | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Pulmonary tuberculosis | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 1/24 (4.2%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Purulent discharge | 2/21 (9.5%) | 0/25 (0%) | 2/21 (9.5%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 4/11 (36.4%) | |||||||
| Rash pustular | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 1/26 (3.8%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Sinusitis | 2/21 (9.5%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Sinusitis bacterial | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Skin candida | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Staphylococcal abscess | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Staphylococcal impetigo | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Streptococcal impetigo | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Subcutaneous abscess | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Tinea capitis | 3/21 (14.3%) | 0/25 (0%) | 8/21 (38.1%) | 6/26 (23.1%) | 2/24 (8.3%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Tinea faciei | 2/21 (9.5%) | 0/25 (0%) | 3/21 (14.3%) | 1/26 (3.8%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Tinea infection | 9/21 (42.9%) | 0/25 (0%) | 7/21 (33.3%) | 3/26 (11.5%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Tinea pedis | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Tinea versicolour | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Tonsillitis | 5/21 (23.8%) | 4/25 (16%) | 8/21 (38.1%) | 9/26 (34.6%) | 4/24 (16.7%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Urinary tract infection | 2/21 (9.5%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Varicella | 1/21 (4.8%) | 1/25 (4%) | 2/21 (9.5%) | 3/26 (11.5%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Arthropod bite | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 3/26 (11.5%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Contusion | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Excoriation | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Skin abrasion | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Investigations | ||||||||||||||
| Alanine aminotransferase increased | 13/21 (61.9%) | 14/25 (56%) | 14/21 (66.7%) | 15/26 (57.7%) | 15/24 (62.5%) | 5/14 (35.7%) | 7/11 (63.6%) | |||||||
| Aspartate aminotransferase increased | 12/21 (57.1%) | 16/25 (64%) | 14/21 (66.7%) | 15/26 (57.7%) | 19/24 (79.2%) | 5/14 (35.7%) | 5/11 (45.5%) | |||||||
| Bilirubin conjugated increased | 14/21 (66.7%) | 13/25 (52%) | 13/21 (61.9%) | 19/26 (73.1%) | 19/24 (79.2%) | 7/14 (50%) | 5/11 (45.5%) | |||||||
| Blood alkaline phosphatase increased | 7/21 (33.3%) | 5/25 (20%) | 4/21 (19%) | 6/26 (23.1%) | 8/24 (33.3%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Blood bilirubin | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Blood bilirubin increased | 12/21 (57.1%) | 12/25 (48%) | 12/21 (57.1%) | 18/26 (69.2%) | 13/24 (54.2%) | 7/14 (50%) | 8/11 (72.7%) | |||||||
| Blood bilirubin unconjugated | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 3/26 (11.5%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Blood bilirubin unconjugated increased | 19/21 (90.5%) | 16/25 (64%) | 14/21 (66.7%) | 18/26 (69.2%) | 14/24 (58.3%) | 11/14 (78.6%) | 8/11 (72.7%) | |||||||
| Blood calcium abnormal | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Blood calcium decreased | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 1/26 (3.8%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Blood calcium increased | 0/21 (0%) | 2/25 (8%) | 3/21 (14.3%) | 3/26 (11.5%) | 0/24 (0%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Blood cholesterol abnormal | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Blood cholesterol increased | 10/21 (47.6%) | 11/25 (44%) | 17/21 (81%) | 22/26 (84.6%) | 13/24 (54.2%) | 7/14 (50%) | 7/11 (63.6%) | |||||||
| Blood creatine phosphokinase increased | 6/21 (28.6%) | 1/25 (4%) | 3/21 (14.3%) | 1/26 (3.8%) | 2/24 (8.3%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Blood creatinine increased | 13/21 (61.9%) | 5/25 (20%) | 6/21 (28.6%) | 8/26 (30.8%) | 11/24 (45.8%) | 4/14 (28.6%) | 3/11 (27.3%) | |||||||
| Blood glucose abnormal | 2/21 (9.5%) | 2/25 (8%) | 3/21 (14.3%) | 3/26 (11.5%) | 4/24 (16.7%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Blood glucose decreased | 15/21 (71.4%) | 18/25 (72%) | 16/21 (76.2%) | 22/26 (84.6%) | 14/24 (58.3%) | 3/14 (21.4%) | 6/11 (54.5%) | |||||||
| Blood glucose increased | 7/21 (33.3%) | 9/25 (36%) | 4/21 (19%) | 10/26 (38.5%) | 8/24 (33.3%) | 3/14 (21.4%) | 2/11 (18.2%) | |||||||
| Blood magnesium decreased | 2/21 (9.5%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Blood potassium abnormal | 6/21 (28.6%) | 6/25 (24%) | 14/21 (66.7%) | 12/26 (46.2%) | 12/24 (50%) | 1/14 (7.1%) | 9/11 (81.8%) | |||||||
| Blood potassium decreased | 10/21 (47.6%) | 7/25 (28%) | 10/21 (47.6%) | 13/26 (50%) | 8/24 (33.3%) | 4/14 (28.6%) | 3/11 (27.3%) | |||||||
| Blood potassium increased | 6/21 (28.6%) | 9/25 (36%) | 17/21 (81%) | 18/26 (69.2%) | 9/24 (37.5%) | 1/14 (7.1%) | 7/11 (63.6%) | |||||||
| Blood sodium abnormal | 1/21 (4.8%) | 3/25 (12%) | 1/21 (4.8%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Blood sodium decreased | 17/21 (81%) | 17/25 (68%) | 17/21 (81%) | 23/26 (88.5%) | 18/24 (75%) | 5/14 (35.7%) | 10/11 (90.9%) | |||||||
| Blood sodium increased | 4/21 (19%) | 4/25 (16%) | 3/21 (14.3%) | 2/26 (7.7%) | 6/24 (25%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Blood triglycerides increased | 19/21 (90.5%) | 19/25 (76%) | 20/21 (95.2%) | 25/26 (96.2%) | 19/24 (79.2%) | 7/14 (50%) | 10/11 (90.9%) | |||||||
| Blood urea abnormal | 4/21 (19%) | 4/25 (16%) | 2/21 (9.5%) | 4/26 (15.4%) | 3/24 (12.5%) | 0/14 (0%) | 4/11 (36.4%) | |||||||
| Blood uric acid increased | 1/21 (4.8%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Breath sounds abnormal | 3/21 (14.3%) | 1/25 (4%) | 3/21 (14.3%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Cardiac murmur | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Gamma-glutamyltransferase increased | 6/21 (28.6%) | 12/25 (48%) | 12/21 (57.1%) | 14/26 (53.8%) | 10/24 (41.7%) | 5/14 (35.7%) | 5/11 (45.5%) | |||||||
| Haemoglobin decreased | 11/21 (52.4%) | 11/25 (44%) | 14/21 (66.7%) | 21/26 (80.8%) | 12/24 (50%) | 3/14 (21.4%) | 6/11 (54.5%) | |||||||
| High density lipoprotein abnormal | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Low density lipoprotein abnormal | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Neutrophil count decreased | 11/21 (52.4%) | 11/25 (44%) | 19/21 (90.5%) | 17/26 (65.4%) | 14/24 (58.3%) | 7/14 (50%) | 8/11 (72.7%) | |||||||
| Pancreatic enzymes abnormal | 0/21 (0%) | 2/25 (8%) | 7/21 (33.3%) | 1/26 (3.8%) | 3/24 (12.5%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Weight decreased | 3/21 (14.3%) | 4/25 (16%) | 3/21 (14.3%) | 2/26 (7.7%) | 5/24 (20.8%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Abnormal weight gain | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Decreased appetite | 4/21 (19%) | 3/25 (12%) | 7/21 (33.3%) | 10/26 (38.5%) | 4/24 (16.7%) | 1/14 (7.1%) | 5/11 (45.5%) | |||||||
| Failure to thrive | 1/21 (4.8%) | 3/25 (12%) | 3/21 (14.3%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Hyperkalaemia | 0/21 (0%) | 1/25 (4%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Hyponatraemia | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 3/21 (14.3%) | 2/25 (8%) | 0/21 (0%) | 2/26 (7.7%) | 1/24 (4.2%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Clubbing | 4/21 (19%) | 1/25 (4%) | 4/21 (19%) | 6/26 (23.1%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Joint swelling | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Lower extremity mass | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Musculoskeletal discomfort | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Musculoskeletal stiffness | 2/21 (9.5%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Myalgia | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Pain in extremity | 4/21 (19%) | 4/25 (16%) | 3/21 (14.3%) | 3/26 (11.5%) | 4/24 (16.7%) | 2/14 (14.3%) | 0/11 (0%) | |||||||
| Pain in jaw | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Skin papilloma | 0/21 (0%) | 1/25 (4%) | 1/21 (4.8%) | 2/26 (7.7%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Amnesia | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Dizziness | 3/21 (14.3%) | 4/25 (16%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Epilepsy | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Febrile convulsion | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Headache | 9/21 (42.9%) | 7/25 (28%) | 3/21 (14.3%) | 6/26 (23.1%) | 4/24 (16.7%) | 2/14 (14.3%) | 1/11 (9.1%) | |||||||
| Paraesthesia | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Psychomotor hyperactivity | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Seizure | 1/21 (4.8%) | 0/25 (0%) | 3/21 (14.3%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Somnolence | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||
| Pregnancy | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Agoraphobia | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Anger | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Anxiety disorder | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Attention deficit/hyperactivity disorder | 1/21 (4.8%) | 0/25 (0%) | 3/21 (14.3%) | 1/26 (3.8%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Depression | 1/21 (4.8%) | 2/25 (8%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 3/14 (21.4%) | 0/11 (0%) | |||||||
| Insomnia | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Major depression | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Panic disorder | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Dysuria | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 2/26 (7.7%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Enuresis | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Proteinuria | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Urinary incontinence | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Reproductive system and breast disorders | ||||||||||||||
| Amenorrhoea | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Fibrocystic breast disease | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Genital rash | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Perineal rash | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Vaginal discharge | 1/21 (4.8%) | 3/25 (12%) | 0/21 (0%) | 3/26 (11.5%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Vaginal haemorrhage | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Vulval disorder | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Vulvovaginal pruritus | 2/21 (9.5%) | 1/25 (4%) | 0/21 (0%) | 1/26 (3.8%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Vulvovaginal rash | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Asthma | 3/21 (14.3%) | 1/25 (4%) | 5/21 (23.8%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Bronchial hyperreactivity | 1/21 (4.8%) | 2/25 (8%) | 1/21 (4.8%) | 5/26 (19.2%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Bronchiectasis | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Bronchospasm | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Cough | 20/21 (95.2%) | 16/25 (64%) | 19/21 (90.5%) | 26/26 (100%) | 18/24 (75%) | 9/14 (64.3%) | 9/11 (81.8%) | |||||||
| Dry throat | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Dyspnoea | 1/21 (4.8%) | 1/25 (4%) | 7/21 (33.3%) | 2/26 (7.7%) | 0/24 (0%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Epistaxis | 2/21 (9.5%) | 0/25 (0%) | 4/21 (19%) | 2/26 (7.7%) | 2/24 (8.3%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Interstitial lung disease | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Laryngeal inflammation | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Nasal congestion | 9/21 (42.9%) | 4/25 (16%) | 10/21 (47.6%) | 14/26 (53.8%) | 7/24 (29.2%) | 3/14 (21.4%) | 4/11 (36.4%) | |||||||
| Nasal oedema | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Nasal ulcer | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Oropharyngeal pain | 8/21 (38.1%) | 7/25 (28%) | 5/21 (23.8%) | 11/26 (42.3%) | 7/24 (29.2%) | 3/14 (21.4%) | 1/11 (9.1%) | |||||||
| Paranasal sinus hypersecretion | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 2/11 (18.2%) | |||||||
| Pharyngeal erythema | 8/21 (38.1%) | 0/25 (0%) | 3/21 (14.3%) | 5/26 (19.2%) | 1/24 (4.2%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Pharyngeal inflammation | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Pneumonia aspiration | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Pulmonary congestion | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 2/26 (7.7%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Rales | 3/21 (14.3%) | 1/25 (4%) | 3/21 (14.3%) | 5/26 (19.2%) | 6/24 (25%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Respiratory tract congestion | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 2/24 (8.3%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Rhinorrhoea | 13/21 (61.9%) | 7/25 (28%) | 13/21 (61.9%) | 19/26 (73.1%) | 7/24 (29.2%) | 4/14 (28.6%) | 7/11 (63.6%) | |||||||
| Rhonchi | 0/21 (0%) | 1/25 (4%) | 0/21 (0%) | 4/26 (15.4%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Sinus congestion | 0/21 (0%) | 1/25 (4%) | 1/21 (4.8%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Sneezing | 1/21 (4.8%) | 0/25 (0%) | 1/21 (4.8%) | 3/26 (11.5%) | 1/24 (4.2%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Tachypnoea | 0/21 (0%) | 1/25 (4%) | 2/21 (9.5%) | 1/26 (3.8%) | 1/24 (4.2%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Throat irritation | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Tonsillar hypertrophy | 2/21 (9.5%) | 1/25 (4%) | 2/21 (9.5%) | 4/26 (15.4%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Wheezing | 3/21 (14.3%) | 2/25 (8%) | 4/21 (19%) | 8/26 (30.8%) | 4/24 (16.7%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Acne | 3/21 (14.3%) | 2/25 (8%) | 0/21 (0%) | 3/26 (11.5%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Blister | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Dermatitis allergic | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Dermatitis atopic | 1/21 (4.8%) | 0/25 (0%) | 1/21 (4.8%) | 2/26 (7.7%) | 0/24 (0%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Dermatitis diaper | 0/21 (0%) | 0/25 (0%) | 5/21 (23.8%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 3/11 (27.3%) | |||||||
| Drug eruption | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Dry skin | 4/21 (19%) | 0/25 (0%) | 2/21 (9.5%) | 4/26 (15.4%) | 3/24 (12.5%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Eczema | 3/21 (14.3%) | 4/25 (16%) | 7/21 (33.3%) | 6/26 (23.1%) | 4/24 (16.7%) | 0/14 (0%) | 3/11 (27.3%) | |||||||
| Eosinophilic pustular folliculitis | 0/21 (0%) | 2/25 (8%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Erythema | 4/21 (19%) | 0/25 (0%) | 3/21 (14.3%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 1/11 (9.1%) | |||||||
| Exfoliative rash | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Facial wasting | 1/21 (4.8%) | 0/25 (0%) | 6/21 (28.6%) | 5/26 (19.2%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Lipoatrophy | 2/21 (9.5%) | 0/25 (0%) | 1/21 (4.8%) | 1/26 (3.8%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Lipodystrophy acquired | 1/21 (4.8%) | 0/25 (0%) | 2/21 (9.5%) | 1/26 (3.8%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Neurodermatitis | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Papule | 0/21 (0%) | 1/25 (4%) | 1/21 (4.8%) | 2/26 (7.7%) | 0/24 (0%) | 1/14 (7.1%) | 1/11 (9.1%) | |||||||
| Pityriasis alba | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Pruritus | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 3/26 (11.5%) | 3/24 (12.5%) | 2/14 (14.3%) | 0/11 (0%) | |||||||
| Pruritus generalised | 0/21 (0%) | 0/25 (0%) | 1/21 (4.8%) | 1/26 (3.8%) | 1/24 (4.2%) | 2/14 (14.3%) | 0/11 (0%) | |||||||
| Rash | 12/21 (57.1%) | 11/25 (44%) | 16/21 (76.2%) | 13/26 (50%) | 11/24 (45.8%) | 4/14 (28.6%) | 7/11 (63.6%) | |||||||
| Rash generalised | 3/21 (14.3%) | 3/25 (12%) | 7/21 (33.3%) | 7/26 (26.9%) | 3/24 (12.5%) | 1/14 (7.1%) | 2/11 (18.2%) | |||||||
| Rash macular | 1/21 (4.8%) | 1/25 (4%) | 0/21 (0%) | 2/26 (7.7%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Rash papular | 1/21 (4.8%) | 1/25 (4%) | 1/21 (4.8%) | 2/26 (7.7%) | 3/24 (12.5%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Skin discolouration | 2/21 (9.5%) | 0/25 (0%) | 0/21 (0%) | 1/26 (3.8%) | 1/24 (4.2%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Skin hyperpigmentation | 1/21 (4.8%) | 1/25 (4%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Skin lesion | 7/21 (33.3%) | 0/25 (0%) | 8/21 (38.1%) | 12/26 (46.2%) | 9/24 (37.5%) | 0/14 (0%) | 3/11 (27.3%) | |||||||
| Skin plaque | 1/21 (4.8%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 1/24 (4.2%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Skin ulcer | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 0/24 (0%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Swelling face | 0/21 (0%) | 0/25 (0%) | 2/21 (9.5%) | 0/26 (0%) | 4/24 (16.7%) | 0/14 (0%) | 0/11 (0%) | |||||||
| Umbilical haematoma | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Urticaria | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 3/26 (11.5%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
| Urticaria chronic | 0/21 (0%) | 0/25 (0%) | 0/21 (0%) | 0/26 (0%) | 0/24 (0%) | 1/14 (7.1%) | 0/11 (0%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
| Name/Title | Melissa Allen, Director, IMPAACT Operations Center |
|---|---|
| Organization | Family Health International (FHI 360) |
| Phone | (919) 405-1429 |
| mallen@fhi360.org |
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006604
Other Study ID Numbers:
- P1020A
- 10037
- IMPAACT P1020A
- PACTG P1020-A
- ACTG P1020-A
First Posted:
Aug 31, 2001
Last Update Posted:
Nov 5, 2021
Last Verified:
Mar 1, 2016