An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
Sponsor
ViiV Healthcare (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00791700
Collaborator
Pfizer (Industry)
103
41
1
170.3
2.5
0
Study Details
Study Description
Brief Summary
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
103 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC, SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2 - <18 YEARS OF AGE
Actual Study Start Date
:
Apr 22, 2009
Actual Primary Completion Date
:
Apr 14, 2015
Anticipated Study Completion Date
:
Jun 30, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Maraviroc Subjects will be stratified by age and formulation into one of the following cohorts: Cohort 1: ≥2-<6 years of age, maraviroc liquid formulation; Cohort 2: ≥6-<12 years of age, maraviroc tablet formulation; Cohort 3: ≥6-<12 years of age, maraviroc liquid formulation and Cohort 4: ≥12-<18 years of age, maraviroc tablet formulation. |
Drug: Maraviroc
Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) [Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)]
Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.
- Area Under the Curve at Steady State (AUCtau) [Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)]
AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.
- Time to Reach Maximum Plasma Concentration (Tmax) [Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)]
- Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) [Baseline up to 5 years]
Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.
- Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug [Baseline up to 5 years]
The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.
Secondary Outcome Measures
- Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach [Week 24 and Week 48 post-treatment]
The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
- Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach [Week 24 and Week 48 post-treatment]
The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
- Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach [Week 24 and Week 48 post-treatment]
Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].
- Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach [Week 24 and Week 48 post-treatment]
Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].
- Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 [Week 48]
TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.
- Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 [Baseline to Week 24, Week 48 post-treatment]
Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.
- Change From Baseline in HIV-1 RNA (Original) [Baseline, Week 24, Week 48 post-treatment]
Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.
- Change From Baseline in HIV-1 RNA (Log10 Copies/mL) [Baseline, Week 24, Week 48 post-treatment]
Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 [Baseline, Week 24, Week 48 post-treatment]
Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
- Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 [Baseline, Week 24 and Week 48 post-treatment]
Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
- Number of Participants With Protocol Defined Virologic Failure [Week 48]
The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days.
- Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 [Screening to Week 48]
Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.
- Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF [48 weeks]
Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.
- Percentage of Participants With Optimized Background Treatment Susceptibility Scores [48 weeks]
Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, >=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and >=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL
Exclusion Criteria:
-
X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay
-
Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs)
-
Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase;
-
Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST < 2.5 X ULN; No symptoms other than jaundice or icterus.
-
Other laboratory values ≥Grade 3, must be reviewed by Pfizer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 2 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 3 | Alfred I. DuPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 4 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 5 | Rainbow Center at University of Florida Health | Jacksonville | Florida | United States | 32209 |
| 6 | University of Miami Miller School of Medicine | Miami | Florida | United States | 33136 |
| 7 | University of South Florida | Tampa | Florida | United States | 33612 |
| 8 | Grady Health System, IDP | Atlanta | Georgia | United States | 30308 |
| 9 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30322 |
| 10 | Pediatric Infectious Disease Clinic | Jackson | Mississippi | United States | 39213 |
| 11 | Batson Specialty Clinic | Jackson | Mississippi | United States | 39216 |
| 12 | University of Mississippi | Jackson | Mississippi | United States | 39216 |
| 13 | Cincinnati Center for Clinical Research | Cincinnati | Ohio | United States | 45206 |
| 14 | Children's Medical Center of Dallas | Dallas | Texas | United States | 75235 |
| 15 | Children's Memorial Hermann Hospital | Houston | Texas | United States | 77030 |
| 16 | UT Physician | Houston | Texas | United States | 77030 |
| 17 | VCU Health System Clinical Research Services | Richmond | Virginia | United States | 23298 |
| 18 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 19 | Instituto de Infectologia Emilio Ribas | São Paulo | SP | Brazil | 01246-900 |
| 20 | Condomínio Edifício Parque Paulista | São Paulo | Brazil | 01416-000 | |
| 21 | Clinica Pediatrica Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 22 | Farmacia Interna | Padova | Italy | 35128 | |
| 23 | IRCCS Ospedale Pediatrico Bambino Gesu | Roma | Italy | 00165 | |
| 24 | Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive | Torino | Italy | 10126 | |
| 25 | Hospital Infantil de Mexico Federico Gomez | Mexico | DF | Mexico | 06720 |
| 26 | Centro Hospitalar Universitario do Algarve, EPE | Faro | Portugal | 8000-386 | |
| 27 | Centro Hospitalar de Lisboa Central, EPE | Lisboa | Portugal | 1169-045 | |
| 28 | Centro Hospitalar de Lisboa Norte, EPE | Lisboa | Portugal | 1649-035 | |
| 29 | Hospital S. João, E.P.E | Porto | Portugal | 4202-451 | |
| 30 | Hospital San Juan Research Unit | San Juan | Puerto Rico | 00935 | |
| 31 | Iatros International | Bloemfontein | FREE State | South Africa | 9301 |
| 32 | Lakeview Hospital | Benoni | Gauteng | South Africa | 1501 |
| 33 | Dr George Mukhari Hospital | Ga-Rankuwa | Gauteng | South Africa | 0208 |
| 34 | Dr. Jan Fourie Medical Centre | Dundee | Kwazulu-natal | South Africa | 3000 |
| 35 | Embassy Drive Medical Center | Pretoria | South Africa | 0083 | |
| 36 | Hospital Sant Joan de Deu | Esplugues De Llobregat, Barcelona | Spain | 08950 | |
| 37 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 38 | Department of Pediatrics, Faculty of Medicine, Chiang Mai University | Muang | Chiang MAI | Thailand | 50200 |
| 39 | Department of Pediatric, Faculty of Medicine, Khon Kaen University | Muang | Khon Kaen | Thailand | 40002 |
| 40 | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), | Bangkok | Thailand | 10330 | |
| 41 | Department of Pediatrics, Faculty of Medicine, Siriraj Hospital | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- ViiV Healthcare
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00791700
Other Study ID Numbers:
- A4001031
- 2008-006873-33
First Posted:
Nov 14, 2008
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ViiV Healthcare
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This open-label, multicenter, multiple dose pharmacokinetic, safety and efficacy study at 24 sites in 8 countries. |
|---|---|
| Pre-assignment Detail | The participants were HIV-1 infected treatment-experienced children and adolescents who were failing current antiretroviral (ARV) therapy or have failed their most recent ARV regimen, defined by plasma HIV-1 RNA>=1000 copies/mL, were infected with only R5 HIV-1, and have ARV experience/intolerance of 6 months with at least 2 ARV drug classes. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 milligram per milliliter [mg/mL]). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 milligram [mg], 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Period Title: Overall Study | ||||
| STARTED | 16 | 31 | 13 | 43 |
| COMPLETED | 10 | 20 | 7 | 13 |
| NOT COMPLETED | 6 | 11 | 6 | 30 |
Baseline Characteristics
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation | Total |
|---|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | Total of all reporting groups |
| Overall Participants | 16 | 31 | 13 | 43 | 103 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
3.4
(0.9)
|
9.1
(1.7)
|
8.9
(2.0)
|
14.0
(1.6)
|
10.3
(4.1)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
5
31.3%
|
16
51.6%
|
6
46.2%
|
27
62.8%
|
54
52.4%
|
| Male |
11
68.8%
|
15
48.4%
|
7
53.8%
|
16
37.2%
|
49
47.6%
|
Outcome Measures
| Title | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) |
|---|---|
| Description | Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean. |
| Time Frame | Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed": participants evaluable at specified time points for this measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 12 | 11 | 10 | 17 |
| Cavg-Week2 |
237.34
(63)
|
260.65
(43)
|
264.45
(62)
|
239.85
(67)
|
| Cavg-Week 48 |
163.73
(146)
|
289.69
(50)
|
168.62
(117)
|
199.12
(78)
|
| Cmax-Week2 |
581.47
(69)
|
546.80
(51)
|
444.37
(61)
|
530.80
(62)
|
| Cmax-Week 48 |
334.68
(156)
|
593.68
(25)
|
284.96
(128)
|
423.32
(48)
|
| Cmin-Week2 |
18.97
(202208)
|
100.02
(39)
|
115.84
(90)
|
56.17
(145)
|
| Cmin-Week 48 |
48.11
(180)
|
82.21
(120)
|
60.03
(245)
|
66.51
(140)
|
| Title | Area Under the Curve at Steady State (AUCtau) |
|---|---|
| Description | AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours. |
| Time Frame | Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed" signifies participants evaluable at specified time points for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 12 | 11 | 10 | 17 |
| AUCtau - Week 2 |
2848.1
(63)
|
3127.7
(43)
|
3173.4
(62)
|
2878.2
(67)
|
| AUCtau - Week 48 |
1964.7
(146)
|
3476.3
(50)
|
2023.5
(117)
|
2389.4
(78)
|
| Title | Time to Reach Maximum Plasma Concentration (Tmax) |
|---|---|
| Description | |
| Time Frame | Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed" signifies participants evaluable at specified time points for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 12 | 11 | 10 | 17 |
| Tmax - Week 2 |
2.000
|
4.000
|
2.000
|
2.000
|
| Tmax - Week 48 |
2.000
|
2.000
|
3.000
|
2.000
|
| Title | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) |
|---|---|
| Description | Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term. |
| Time Frame | Baseline up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis was performed on all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Cohort 1 (Grade 3) | Cohort 1 (Grade 4) | Cohort 2 (Grade 3) | Cohort 2 (Grade 4) | Cohort 3 (Grade 3) | Cohort 3 (Grade 4) | Cohort 4 (Grade 3) | Cohort 4 (Grade 4) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 16 | 31 | 31 | 13 | 13 | 43 | 43 |
| Gastrointestinal disorders - Vomiting |
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Hepat. disorders - Drug-induced liver injury |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
| Infections and infestations - H1N1 influenza |
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
| Infections and infestations - Pneumonia |
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
| Investigations - Lipase increased |
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
| Pyschiatric disorder - Bipolar disorder |
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Gastrointestinal disorders - Gastritis |
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Investigations - Hepatic enzyme abnormal |
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Investigations - Transaminases increased |
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Pyschiatric disorder - Aggression |
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Blood and lymphatic system disorders - Anaemia |
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
| Infections and infestations - Meningitis |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
| Infections and infestations -Otitis media |
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
| Title | Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug |
|---|---|
| Description | The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason. |
| Time Frame | Baseline up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis was performed on all participants who received at least 1 dose of study drug. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 31 | 13 | 43 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach |
|---|---|
| Description | The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. |
| Time Frame | Week 24 and Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who receive at least one dose of study medication. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 31 | 13 | 43 |
| Week 24 |
68.8
430%
|
90.3
291.3%
|
69.2
532.3%
|
62.8
146%
|
| Week 48 |
75.0
468.8%
|
77.4
249.7%
|
69.2
532.3%
|
51.2
119.1%
|
| Title | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach |
|---|---|
| Description | The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. |
| Time Frame | Week 24 and Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 31 | 13 | 43 |
| Week 24 |
18.75
117.2%
|
64.5
208.1%
|
61.5
473.1%
|
48.8
113.5%
|
| Week 48 |
50.0
312.5%
|
54.8
176.8%
|
53.8
413.8%
|
39.5
91.9%
|
| Title | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach |
|---|---|
| Description | Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. |
| Time Frame | Week 24 and Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this measure."Number analyzed" signifies participants evaluable at specified time points for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 12 | 27 | 9 | 27 |
| Week 24 |
62.5
390.6%
|
87.10
281%
|
69.2
532.3%
|
62.8
146%
|
| Week 48 |
75.0
468.8%
|
74.2
239.4%
|
69.2
532.3%
|
51.2
119.1%
|
| Title | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach |
|---|---|
| Description | Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. |
| Time Frame | Week 24 and Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this measure."Number analyzed" signifies participants evaluable at specified time points for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 8 | 20 | 8 | 21 |
| Week 24 |
18.8
117.5%
|
64.5
208.1%
|
61.5
473.1%
|
48.8
113.5%
|
| Week 48 |
50.0
312.5%
|
54.8
176.8%
|
53.8
413.8%
|
39.5
91.9%
|
| Title | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 |
|---|---|
| Description | TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 31 | 13 | 43 |
| <400 copies/mL; TLOVR Responder |
62.5
390.6%
|
74.2
239.4%
|
69.2
532.3%
|
48.8
113.5%
|
| <48 copies/mL; TLOVR Responder |
43.8
273.8%
|
54.8
176.8%
|
46.2
355.4%
|
44.2
102.8%
|
| Title | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 |
|---|---|
| Description | Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated. |
| Time Frame | Baseline to Week 24, Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. Last Observation Carried Forward (LOCF) was used to impute missing values. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 31 | 13 | 43 |
| Baseline to Week 24 |
92.3
576.9%
|
100.0
322.6%
|
100.0
769.2%
|
93.1
216.5%
|
| Baseline to Week 48 |
100.0
625%
|
96.2
310.3%
|
100.0
769.2%
|
88.0
204.7%
|
| Title | Change From Baseline in HIV-1 RNA (Original) |
|---|---|
| Description | Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study. |
| Time Frame | Baseline, Week 24, Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 15 | 31 | 12 | 39 |
| Change from Baseline - Original - Week 24 |
-271974.6
(391843.59)
|
-38764.0
(63688.93)
|
-58081.0
(79720.33)
|
-57325.7
(172108.62)
|
| Change from Baseline - Original - Week 48 |
-267834.2
(378896.88)
|
-34787.7
(60222.60)
|
-56351.7
(76231.03)
|
-55321.1
(173840.55)
|
| Title | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) |
|---|---|
| Description | Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study. |
| Time Frame | Baseline, Week 24, Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 15 | 31 | 12 | 39 |
| Change from Baseline - Log10 - Week 24 |
-2.4853
(1.1421)
|
-2.2324
(0.8668)
|
-2.1756
(1.1854)
|
-1.6482
(1.3806)
|
| Change from Baseline - Log10 - Week 48 |
-2.5831
(1.2148)
|
-1.9579
(1.0861)
|
-2.0549
(1.2125)
|
-1.4591
(1.4477)
|
| Title | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 |
|---|---|
| Description | Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics. |
| Time Frame | Baseline, Week 24, Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 15 | 30 | 12 | 39 |
| Week 24 |
232.7
(381.6)
|
355.8
(294.0)
|
213.9
(166.4)
|
173.6
(203.6)
|
| Week 48 |
275.9
(363.4)
|
362.7
(373.5)
|
167.3
(150.9)
|
168.6
(211.0)
|
| Title | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 |
|---|---|
| Description | Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics. |
| Time Frame | Baseline, Week 24 and Week 48 post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 15 | 31 | 12 | 39 |
| Week 24 |
7.3
(5.0)
|
3.8
(7.4)
|
3.5
(4.0)
|
3.8
(6.1)
|
| Week 48 |
7.5
(7.6)
|
6.0
(6.8)
|
2.5
(4.2)
|
4.6
(6.5)
|
| Title | Number of Participants With Protocol Defined Virologic Failure |
|---|---|
| Description | The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 16 | 31 | 13 | 43 |
| Criteria A |
0
0%
|
2
6.5%
|
1
7.7%
|
5
11.6%
|
| Criteria B |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Criteria C |
3
18.8%
|
3
9.7%
|
2
15.4%
|
8
18.6%
|
| Title | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 |
|---|---|
| Description | Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported. |
| Time Frame | Screening to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 3 | 4 | 3 | 13 |
| With valid on-treatment results |
2
12.5%
|
4
12.9%
|
3
23.1%
|
11
25.6%
|
| Tropism at Confirmed PDVF R5 |
2
12.5%
|
3
9.7%
|
2
15.4%
|
9
20.9%
|
| Tropism at Confirmed PDVF DM |
0
0%
|
1
3.2%
|
1
7.7%
|
2
4.7%
|
| Tropism at Confirmed PDVF X4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Tropism at Confirmed PDVF Not Reportable |
1
6.3%
|
0
0%
|
0
0%
|
1
2.3%
|
| Title | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF |
|---|---|
| Description | Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. |
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation |
|---|---|---|---|---|
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). |
| Measure Participants | 3 | 4 | 3 | 13 |
| With valid on-treatment results |
2
12.5%
|
4
12.9%
|
3
23.1%
|
11
25.6%
|
| PI Minor L10L/F |
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
| PI Minor L89L/I/M |
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
| PI Minor V77V/I |
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
| NNRTI K103K/N |
0
0%
|
1
3.2%
|
0
0%
|
0
0%
|
| NNRTI K103N |
0
0%
|
0
0%
|
1
7.7%
|
1
2.3%
|
| NRTI M184V |
0
0%
|
0
0%
|
1
7.7%
|
0
0%
|
| PI Minor K20K/R |
0
0%
|
0
0%
|
2
15.4%
|
0
0%
|
| Total with emergence |
0
0%
|
1
3.2%
|
3
23.1%
|
4
9.3%
|
| Title | Percentage of Participants With Optimized Background Treatment Susceptibility Scores |
|---|---|
| Description | Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, >=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and >=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Response | PDVF | Other Failure/Remainder |
|---|---|---|---|
| Arm/Group Description | Participants with plasma HIV-1 RNA <48 copies/mL | Participants who meet the protocol-defined virologic failure | Participants with other failures |
| Measure Participants | 49 | 23 | 31 |
| Simple score 0 |
0
0%
|
0
0%
|
0
0%
|
| Simple score 1.0 |
8.2
51.3%
|
4.3
13.9%
|
0
0%
|
| Simple score >=2.0 |
81.6
510%
|
95.7
308.7%
|
96.8
744.6%
|
| Weighted score 0-0.5 |
6.1
38.1%
|
30.4
98.1%
|
29.0
223.1%
|
| Weighted score 1.0-1.5 |
53.1
331.9%
|
65.2
210.3%
|
29.0
223.1%
|
| Weighted score >=2.0 |
28.6
178.8%
|
4.3
13.9%
|
38.7
297.7%
|
Adverse Events
| Time Frame | Baseline up to 5 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. | |||||||
| Arm/Group Title | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation | ||||
| Arm/Group Description | In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). | In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). | In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | ||||
All Cause Mortality |
||||||||
| >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
Serious Adverse Events |
||||||||
| >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/16 (31.3%) | 5/31 (16.1%) | 3/13 (23.1%) | 10/43 (23.3%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Ear and labyrinth disorders | ||||||||
| Otorrhoea | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastric fistula | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Gastritis | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Vomiting | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Constipation | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Diarrhoea | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Drug-induced liver injury | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Infections and infestations | ||||||||
| Abscess oral | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Cellulitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| H1N1 influenza | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pelvic inflammatory disease | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pneumonia | 0/16 (0%) | 1/31 (3.2%) | 1/13 (7.7%) | 2/43 (4.7%) | ||||
| Pulmonary tuberculosis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Tooth abscess | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Viral infection | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Gastroenteritis | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Meningitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Investigations | ||||||||
| Transaminases increased | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Osteopenia | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Pain in extremity | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Tendon disorder | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Psychiatric disorders | ||||||||
| Bipolar disorder | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Hyperventilation | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Prurigo | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/16 (75%) | 25/31 (80.6%) | 10/13 (76.9%) | 34/43 (79.1%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 3/43 (7%) | ||||
| Iron deficiency anaemia | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Lymphadenitis | 1/16 (6.3%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Lymphadenopathy | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 5/43 (11.6%) | ||||
| Neutropenia | 2/16 (12.5%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Cardiac disorders | ||||||||
| Cardiac disorder | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Ear and labyrinth disorders | ||||||||
| Deafness | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Cerumen impaction | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Ear haemorrhage | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Eye disorders | ||||||||
| Conjunctival pallor | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Conjunctivitis allergic | 1/16 (6.3%) | 2/31 (6.5%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Hypermetropia | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Refraction disorder | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Abdominal pain | 0/16 (0%) | 1/31 (3.2%) | 2/13 (15.4%) | 4/43 (9.3%) | ||||
| Abdominal pain lower | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Abdominal pain upper | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Anal pruritus | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Constipation | 2/16 (12.5%) | 1/31 (3.2%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Dental caries | 0/16 (0%) | 1/31 (3.2%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Diarrhoea | 7/16 (43.8%) | 3/31 (9.7%) | 4/13 (30.8%) | 9/43 (20.9%) | ||||
| Dyspepsia | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Flatulence | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Gingival swelling | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Mouth ulceration | 1/16 (6.3%) | 0/31 (0%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Nausea | 0/16 (0%) | 3/31 (9.7%) | 0/13 (0%) | 5/43 (11.6%) | ||||
| Odynophagia | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Proctitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Salivary gland mucocoele | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Tongue disorder | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Toothache | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Vomiting | 6/16 (37.5%) | 8/31 (25.8%) | 3/13 (23.1%) | 4/43 (9.3%) | ||||
| General disorders | ||||||||
| Asthenia | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Fatigue | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Influenza like illness | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Malaise | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pyrexia | 2/16 (12.5%) | 1/31 (3.2%) | 2/13 (15.4%) | 5/43 (11.6%) | ||||
| Hepatobiliary disorders | ||||||||
| Hepatotoxicity | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Hyperbilirubinaemia | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Immune system disorders | ||||||||
| Allergy to arthropod bite | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Infections and infestations | ||||||||
| Abscess | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Acarodermatitis | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Bacterial vaginosis | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Bronchitis | 3/16 (18.8%) | 3/31 (9.7%) | 0/13 (0%) | 7/43 (16.3%) | ||||
| Bullous impetigo | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Conjunctivitis | 2/16 (12.5%) | 2/31 (6.5%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Cystitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Ear infection | 1/16 (6.3%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Fungal skin infection | 1/16 (6.3%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Gastroenteritis | 3/16 (18.8%) | 0/31 (0%) | 2/13 (15.4%) | 2/43 (4.7%) | ||||
| Gastroenteritis viral | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Gingivitis | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Herpes virus infection | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Hordeolum | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Impetigo | 1/16 (6.3%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Influenza | 2/16 (12.5%) | 6/31 (19.4%) | 3/13 (23.1%) | 5/43 (11.6%) | ||||
| Latent tuberculosis | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Lice infestation | 0/16 (0%) | 2/31 (6.5%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Nasopharyngitis | 4/16 (25%) | 4/31 (12.9%) | 0/13 (0%) | 3/43 (7%) | ||||
| Oral herpes | 1/16 (6.3%) | 2/31 (6.5%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Otitis externa | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Otitis media | 6/16 (37.5%) | 1/31 (3.2%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Otitis media acute | 2/16 (12.5%) | 2/31 (6.5%) | 0/13 (0%) | 0/43 (0%) | ||||
| Otitis media chronic | 2/16 (12.5%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Paronychia | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Parotitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pharyngitis | 1/16 (6.3%) | 1/31 (3.2%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Oropharyngeal candidiasis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pharyngotonsillitis | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Pneumonia | 0/16 (0%) | 3/31 (9.7%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Pneumonia bacterial | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Rhinitis | 3/16 (18.8%) | 1/31 (3.2%) | 0/13 (0%) | 3/43 (7%) | ||||
| Sinobronchitis | 0/16 (0%) | 2/31 (6.5%) | 0/13 (0%) | 0/43 (0%) | ||||
| Sinusitis | 1/16 (6.3%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Tinea capitis | 2/16 (12.5%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Tinea faciei | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Tinea infection | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Tonsillitis | 1/16 (6.3%) | 2/31 (6.5%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Tooth abscess | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Tracheitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Tuberculosis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Upper respiratory tract infection | 7/16 (43.8%) | 6/31 (19.4%) | 2/13 (15.4%) | 5/43 (11.6%) | ||||
| Varicella | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Viral infection | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Viral upper respiratory tract infection | 3/16 (18.8%) | 2/31 (6.5%) | 3/13 (23.1%) | 1/43 (2.3%) | ||||
| Vulvovaginitis | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Wound infection | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Conjunctivitis bacterial | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Mastoiditis | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Viral rash | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Fungal infection | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pulmonary tuberculosis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Urinary tract infection | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Angular cheilitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Accidental exposure to product | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Arthropod bite | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Arthropod sting | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Contusion | 0/16 (0%) | 2/31 (6.5%) | 0/13 (0%) | 0/43 (0%) | ||||
| Fall | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Foot fracture | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Head injury | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Injury | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Ligament sprain | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Limb injury | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Muscle strain | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Overdose | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Skin abrasion | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Thermal burn | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Underdose | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Accidental overdose | 1/16 (6.3%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Ankle fracture | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Traumatic ulcer | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Traumatic haematoma | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Investigations | ||||||||
| Blood HIV RNA increased | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Blood alkaline phosphatase increased | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Blood creatine phosphokinase increased | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Blood iron decreased | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Blood phosphorus decreased | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Cardiac murmur | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Hepatic enzyme abnormal | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Hepatic enzyme increased | 1/16 (6.3%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Lipase increased | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Neutrophil count decreased | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Viral load increased | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Weight decreased | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Weight increased | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Haemoglobin decreased | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Dehydration | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Hyperglycaemia | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Hypertriglyceridaemia | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Hypokalaemia | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Insulin resistance | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Vitamin D deficiency | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/16 (0%) | 2/31 (6.5%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Back pain | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Bone swelling | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Bursitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Joint swelling | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Musculoskeletal discomfort | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Myofascial pain syndrome | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Osteoporosis | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Pain in extremity | 0/16 (0%) | 1/31 (3.2%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Musculoskeletal stiffness | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Myalgia | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Skin papilloma | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 3/43 (7%) | ||||
| Epilepsy | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Generalised tonic-clonic seizure | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Headache | 0/16 (0%) | 2/31 (6.5%) | 2/13 (15.4%) | 6/43 (14%) | ||||
| Lethargy | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Somnolence | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Tension headache | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Intellectual disability | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Pregnancy | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Psychiatric disorders | ||||||||
| Attention deficit/hyperactivity disorder | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Depression | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Hallucination | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Insomnia | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Nightmare | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 0/43 (0%) | ||||
| Panic disorder | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Aggression | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Flat affect | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Reproductive system and breast disorders | ||||||||
| Amenorrhoea | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Breast enlargement | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Breast mass | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Breast pain | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Dysmenorrhoea | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Bronchospasm | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Catarrh | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Cough | 1/16 (6.3%) | 6/31 (19.4%) | 2/13 (15.4%) | 3/43 (7%) | ||||
| Epistaxis | 1/16 (6.3%) | 2/31 (6.5%) | 0/13 (0%) | 0/43 (0%) | ||||
| Hyperventilation | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Nasal congestion | 0/16 (0%) | 1/31 (3.2%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Oropharyngeal pain | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Pharyngeal disorder | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Productive cough | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Respiratory disorder | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Rhinitis allergic | 0/16 (0%) | 2/31 (6.5%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Rhinorrhoea | 0/16 (0%) | 2/31 (6.5%) | 1/13 (7.7%) | 2/43 (4.7%) | ||||
| Rhonchi | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Bronchial hyperreactivity | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Allergic cough | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Acanthosis nigricans | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Acne | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Dermatitis | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 2/43 (4.7%) | ||||
| Dermatitis allergic | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Dermatitis contact | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Dermatitis diaper | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Dry skin | 0/16 (0%) | 0/31 (0%) | 2/13 (15.4%) | 1/43 (2.3%) | ||||
| Ecchymosis | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Eczema | 0/16 (0%) | 0/31 (0%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Papule | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Prurigo | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Rash | 3/16 (18.8%) | 1/31 (3.2%) | 1/13 (7.7%) | 1/43 (2.3%) | ||||
| Rash pruritic | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Skin lesion | 0/16 (0%) | 0/31 (0%) | 2/13 (15.4%) | 0/43 (0%) | ||||
| Urticaria | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Urticaria papular | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Lipodystrophy acquired | 0/16 (0%) | 1/31 (3.2%) | 0/13 (0%) | 0/43 (0%) | ||||
| Neurodermatitis | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
| Surgical and medical procedures | ||||||||
| Tooth extraction | 1/16 (6.3%) | 0/31 (0%) | 0/13 (0%) | 0/43 (0%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 0/16 (0%) | 0/31 (0%) | 0/13 (0%) | 1/43 (2.3%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00791700
Other Study ID Numbers:
- A4001031
- 2008-006873-33
First Posted:
Nov 14, 2008
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020