Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Completed
CT.gov ID
NCT00099359
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
1,735
17
3
84
102.1
1.2
Study Details
Study Description
Brief Summary
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The one drug standard treatment and two combinations to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3) zidovudine/lamivudine/nelfinavir.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Despite the notable reductions in perinatal transmission of HIV-1 with antiretroviral therapy and other interventions, perinatal transmission continues to occur at rates of 20-30% among pregnant women who are not identified as HIV-1-infected and/or are not provided with antiretroviral therapy. The optimum treatment strategy for prevention of transmission of HIV-1 to infants born to these women is unknown. No trials have evaluated the efficacy of neonatal antiretroviral therapy alone but observational data suggest benefit from zidovudine (ZDV) therapy given to the infant beginning within 48 hours of birth and continued for six weeks. This protocol will compare the safety and efficacy of three antiretroviral regimens administered in the neonatal period: Arm A- ZDV, Arm B- ZDV plus nevirapine (NVP), and Arm C- ZDV plus nelfinavir (NFV) and lamivudine (3TC). Two regimens were selected based on expected antiretroviral activity, pharmacokinetic data, and toxicity profiles. Standard of care (6 weeks of ZDV) alone will be compared to the 6 weeks of ZDV plus either 3 doses of NVP or 2 weeks of 3TC and NFV. Arm B (ZDV + NVP) is the regimen expected to provide the best profile when factors of efficacy, safety, cost, acceptability and convenience are considered. The comparison of Arms B and C is also of considerable interest since the 2-drug Arm B is easier to implement and less expensive than the triple drug Arm C. Although triple drug therapies have been recommended for post-exposure prophylaxis for needle-stick injuries in high-risk circumstances, it is unknown whether the triple drug arm will provide better efficacy than the 2-drug arm for post-exposure prophylaxis of the infant.
This open-label study is expected to accrue 1731 infants of women identified in labor as being HIV positive or who are HIV positive but have not received antiretroviral medication during the pregnancy. If eligible the infant will be randomized at birth to one of three aforementioned treatment arms. Medical history, social, demographic, physical exam, RNA and T- lymphocyte data are collected on the mother during the delivery visit. The infant will have a birth visit and then return for 1-week, 2-week, 4-week, 3-month and a final 6-month visit. Infant evaluations will include: a medical history and physical exam, DNA testing, CBC and liver function tests, cells for long-term storage and RNA/CD4/CD8 testing if HIV positive. The initial study drug doses will be given to the infant while in the hospital. Mothers will administer the infants' remaining treatment doses at home depending on ability.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1735 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission
Study Start Date
:
Feb 1, 2004
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A Standard of care ( Zidovudine only) |
Drug: Zidovudine
Given for 6 weeks. 12mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams
Other Names:
|
| Experimental: B Standard of care (Zidovudine) plus Nevirapine |
Drug: Nevirapine (NVP)
Standard of Care (Zidovudine) plus
NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams
Other Names:
|
| Experimental: C Standard of Care (Zidovudine) plus 2 weeks of Epivir and Nelfinavir |
Drug: Epivir (3TC)
Stand of care (Zidovudine) plus
3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams
Other Names:
Drug: Nelfinavir (NFV)
200 mg BID if birth weight (BW) > 3000 grams for 2 weeks;150 mg BID if BW > 2000-3000 grams for 2 weeks; 100 mg BID BW </= 2000 grams for 2 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Infant HIV Infection Status [3 months]
Intrapartum HIV infection at 3 Months
- Participants With Serious Adverse Events [through age 6 months.]
Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders
Secondary Outcome Measures
- Infant HIV-1 Infection Status [birth]
In utero HIV-1 infection rate
- Participant Deaths [through age 6 months]
- Clinical Covariates of HIV-1 Infection [through age 3 months]
Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.
- 3TC and NFV Pharmacokinetics [through age 14 days]
Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.
- Risk Factors for Perinatal HIV-1 Transmission [through age 3 months]
Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.
- NVP Pharmacokinetics [14 days]
Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 2 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Infants who meet all of the following criteria are eligible for the study:
-
Mother known to be HIV-1-infected prior to labor or identified at the time of labor or <48 hours postpartum. HIV-1 infection for the purposes of enrollment into this study is defined as: (a) Single positive HIV-1 rapid test in mother or her infant; or (b) Historical documentation of a positive HIV-1 diagnostic test confirmed by repeat diagnostic testing for HIV-1 according to country guidelines in mother (written documentation of test results must be present in the medical record).
-
Maternal written informed consent for study participation.
-
Mother has not received any antiretroviral therapy during the current pregnancy prior to the onset of labor and delivery; women may have received intravenous or oral ZDV during labor. Women may have received any antiretroviral therapy in previous pregnancies for prevention of vertical HIV-1 transmission.
-
Infant is <48 hours old. Infant may have received up to 48 hours of ZDV as standard care before study enrollment.
Exclusion Criteria:
Infants who meet any of the following criteria will be excluded from the study:
-
Extreme prematurity (< 32 weeks of gestation).
-
Birth weight <1500 grams.
-
Presence of life-threatening conditions.
-
Inability to take oral medication throughout the first 48 hours of life (must be able to receive oral medication by age 48 hours).
-
Maternal inability to provide informed consent because of a lack of a conscious state, psychiatric conditions, or language barriers.
-
Mother received any antiretroviral therapy during labor and delivery other than intravenous or oral ZDV.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miller Children's Hospital | Long Beach | California | United States | 90806 |
| 2 | University of FL | Gainesville | Florida | United States | 32610-0296 |
| 3 | University of FL-HSC | Jacksonville | Florida | United States | 32209 |
| 4 | University Medical and Dental School of NJ-Newark Campus | Newark | New Jersey | United States | 07103 |
| 5 | Texas Childrens Hospital | Houston | Texas | United States | 77030 |
| 6 | Hospital I. G. A. Dr. Diego Paroissien | Buenos Aires | Argentina | ||
| 7 | Federal University of Minas Gerais (UFMG) | Belo Horizonte | MG | Brazil | 30130-100 |
| 8 | Universidade de Sao Paulo (USP) , MD | São Paulo | Ribeirão Preto | Brazil | 14024-250 |
| 9 | Hospital Fêmina S.A. Unidade Perinatal de Transmissão Vertical | Porto Alegre | Rio Grande do Sul | Brazil | 90430001 |
| 10 | Hospital Santa Casa (HSC) | Porto Alegre | Rio Grande do Sul | Brazil | 90850 530 |
| 11 | Hospital Nossa Senhora da Conceicao (GHC) | Porto Alegre | Rio Grande do Sul | Brazil | 91350-200 |
| 12 | Hospital dos Servidores do Estado (HSE) | Rio de Janeiro | Brazil | 20221-903 | |
| 13 | Hospital Geral de Novo Iguacu | Rio de Janeiro | Brazil | 26030-380 | |
| 14 | 5088 - Universidade Federal de Sao Paulo (UFSP) | São Paulo | Brazil | 04939-002 | |
| 15 | San Juan Hospital | San Juan | Puerto Rico | 00936-8344 | |
| 16 | Tygerberg Hospital | Cape Town | South Africa | ||
| 17 | Chris Hani Baragwanath Hospital | Johannesburg | South Africa |
Sponsors and Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Study Chair: Karin Nielsen, MD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00099359
Other Study ID Numbers:
- NICHD/HPTN 040 (P1043)
First Posted:
Dec 13, 2004
Last Update Posted:
Dec 4, 2012
Last Verified:
Feb 1, 2011
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The first subject was enrolled on 02/27/2004 and the study ended 02/28/2011. A total of 17 sites in Brazil, South Africa, Argentina and the U.S. participated in the study. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm A (ZDV Only) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC + NFV) |
|---|---|---|---|
| Arm/Group Description | Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams | Standard of care (Zidovudine) plus Nevirapine (NVP) NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams | Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams |
| Period Title: Overall Study | |||
| STARTED | 581 | 580 | 574 |
| COMPLETED | 527 | 515 | 506 |
| NOT COMPLETED | 54 | 65 | 68 |
Baseline Characteristics
| Arm/Group Title | Arm A (ZDV Only) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC + NFV) | Total |
|---|---|---|---|---|
| Arm/Group Description | Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams | Standard of care (Zidovudine) plus Nevirapine (NVP) NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams | Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams | Total of all reporting groups |
| Overall Participants | 581 | 580 | 574 | 1735 |
| Age (weeks) [Mean (Standard Deviation) ] | ||||
| Gestational Age in Weeks |
39
(1.7)
|
39
(1.5)
|
39
(1.7)
|
39
(1.7)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
298
51.3%
|
303
52.2%
|
281
49%
|
882
50.8%
|
| Male |
283
48.7%
|
277
47.8%
|
293
51%
|
853
49.2%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
4
0.7%
|
4
0.7%
|
4
0.7%
|
12
0.7%
|
| Puerto Rico |
0
0%
|
1
0.2%
|
1
0.2%
|
2
0.1%
|
| Argentina |
10
1.7%
|
6
1%
|
11
1.9%
|
27
1.6%
|
| Brazil |
409
70.4%
|
408
70.3%
|
402
70%
|
1219
70.3%
|
| South Africa |
158
27.2%
|
161
27.8%
|
156
27.2%
|
475
27.4%
|
Outcome Measures
| Title | Infant HIV Infection Status |
|---|---|
| Description | Intrapartum HIV infection at 3 Months |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis. |
| Arm/Group Title | ARM A (ZDV - Standard of Care) | ARM B (ZDV + NVP) | ARM C (ZDV +3TC+NFV) |
|---|---|---|---|
| Arm/Group Description | ZDV (standard of care), given for 6 weeks: 12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams | plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams | ZDV (standard of care) plus 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams |
| Measure Participants | 566 | 562 | 556 |
| Number [participants] |
24
4.1%
|
11
1.9%
|
12
2.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP), ARM C (ZDV +3TC+NFV) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .046 |
| Comments | Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests. | |
| Method | multiple comparison | |
| Comments | Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms. | |
| Title | Participants With Serious Adverse Events |
|---|---|
| Description | Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders |
| Time Frame | through age 6 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ARM A (ZDV Only) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC/NFV) |
|---|---|---|---|
| Arm/Group Description | ZDV only | ZDV + NVP | ZDV + 3TC/NFV |
| Measure Participants | 566 | 562 | 556 |
| Number [participants] |
86
14.8%
|
59
10.2%
|
110
19.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP), ARM C (ZDV +3TC+NFV) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Infant HIV-1 Infection Status |
|---|---|
| Description | In utero HIV-1 infection rate |
| Time Frame | birth |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (ZDV Only) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC + NFV) |
|---|---|---|---|
| Arm/Group Description | Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams | Standard of care (Zidovudine) plus Nevirapine (NVP) NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams | Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams |
| Measure Participants | 581 | 580 | 574 |
| Number [participants] |
37
6.4%
|
28
4.8%
|
28
4.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP), ARM C (ZDV +3TC+NFV) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .2432 |
| Comments | ||
| Method | multiple comparison | |
| Comments | ||
| Title | Participant Deaths |
|---|---|
| Description | |
| Time Frame | through age 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (ZDV Only) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC + NFV) |
|---|---|---|---|
| Arm/Group Description | Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams | Standard of care (Zidovudine) plus Nevirapine (NVP) NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams | Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams |
| Measure Participants | 581 | 580 | 574 |
| Number [participants] |
11
1.9%
|
15
2.6%
|
17
3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP), ARM C (ZDV +3TC+NFV) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.49 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Clinical Covariates of HIV-1 Infection |
|---|---|
| Description | Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens. |
| Time Frame | through age 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 3TC and NFV Pharmacokinetics |
|---|---|
| Description | Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants. |
| Time Frame | through age 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours. |
| Arm/Group Title | ARM C (ZDV + 3TC/NFV) |
|---|---|
| Arm/Group Description | Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL. |
| Measure Participants | 26 |
| (NFV-AUC-12h) 4-7 day |
20.7
(46.57)
|
| (NFV-AUC-12h) 10-14 day |
25.5
(13.10)
|
| (3TC-AUC-12 h) 4-7 day |
4.0
(4.50)
|
| (3TC-AUC-12h) 10-14 day |
7.9
(4.12)
|
| Title | Risk Factors for Perinatal HIV-1 Transmission |
|---|---|
| Description | Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication. |
| Time Frame | through age 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model. |
| Arm/Group Title | Infected | Uninfected |
|---|---|---|
| Arm/Group Description | Infants infected after birth | Infants uninfected after birth |
| Measure Participants | 47 | 1544 |
| Treatment Arm C (ZDV+3TC/NFV) |
12
2.1%
|
516
89%
|
| Treatment Arm B (ZDV+NFV) |
11
1.9%
|
523
90.2%
|
| Treatment Arm A (ZDV only) |
24
4.1%
|
505
87.1%
|
| Illegal Substance Abuse during pregnancy |
7
1.2%
|
130
22.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.50 | |
| Confidence Interval |
(2-Sided) 95% 0.24 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.39 | |
| Confidence Interval |
(2-Sided) 95% 0.19 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with "NO" being reference group. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.51 | |
| Confidence Interval |
(2-Sided) 95% 1.08 to 5.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | ARM A (ZDV - Standard of Care), ARM B (ZDV + NVP) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.28 | |
| Confidence Interval |
(2-Sided) 95% 1.56 to 3.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | NVP Pharmacokinetics |
|---|---|
| Description | Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants. |
| Time Frame | 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ARM B (ZDV + NVP) |
|---|---|
| Arm/Group Description | NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose. |
| Measure Participants | 14 |
| NVP conc prior to 3rd dose |
362
|
| NVP peak conc (Cmax) post 3rd dose |
2286
|
| NVP conc 3-5 day post 3rd dose |
459
|
| NVP conc 7 day post 3rd dose |
76
|
Adverse Events
| Time Frame | through 6 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AE data collected from study entry to off study period | |||||
| Arm/Group Title | ARM A (ZDV Alone) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC/NFV) | |||
| Arm/Group Description | ZDV, given for 6 weeks: 12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams | ZDV, given for 6 weeks: 12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams | ZDV, given for 6 weeks: 12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams | |||
All Cause Mortality |
||||||
| ARM A (ZDV Alone) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC/NFV) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| ARM A (ZDV Alone) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC/NFV) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 219/581 (37.7%) | 211/580 (36.4%) | 252/574 (43.9%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia Nos | 48/581 (8.3%) | 51 | 28/580 (4.8%) | 32 | 39/574 (6.8%) | 46 |
| Axillary Lymphadenitis | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Disseminated Intravascular Coagulation | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Isoimmune Haemolytic Disease | 0/581 (0%) | 0 | 1/580 (0.2%) | 3 | 0/574 (0%) | 0 |
| Leukocytosis | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Neutropenia | 33/581 (5.7%) | 34 | 33/580 (5.7%) | 40 | 71/574 (12.4%) | 83 |
| Polycythaemia Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Thrombocythaemia | 3/581 (0.5%) | 3 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Thrombocytopenia | 5/581 (0.9%) | 5 | 4/580 (0.7%) | 4 | 9/574 (1.6%) | 10 |
| Cardiac disorders | ||||||
| Cardio-Respiratory Arrest | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cyanosis Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pulmonary Valve Stenosis | 1/581 (0.2%) | 1 | 2/580 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Tachycardia Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Tricuspid Valve Incompetence | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cardiac Disorder Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cardiac Failure Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Congenital Cardiac Septal Defect Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||
| Congenital Atrial Septal Defect | 5/581 (0.9%) | 5 | 4/580 (0.7%) | 4 | 4/574 (0.7%) | 4 |
| Congenital Choroid Plexus Cyst | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Congenital Clubfoot | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Congenital Cytomegalovirus Infection | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Congenital Infection Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Congenital Macrocephaly | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Congenital Syphilis | 47/581 (8.1%) | 47 | 52/580 (9%) | 52 | 42/574 (7.3%) | 43 |
| Congenital Toxoplasmosis | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Congenital Ventricular Septal Defect | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 2/574 (0.3%) | 2 |
| Foetal Alcohol Syndrome | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Genitalia External Ambiguous | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Meningomyelocele | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Patent Ductus Arteriosus | 0/581 (0%) | 0 | 2/580 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Retinoblastoma Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Trisomy 21 | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Urethral Valves | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Eye disorders | ||||||
| Neonatal Conjunctivitis Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Acquired Pyloric Stenosis | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Constipation | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Diarrhoea Nos | 4/581 (0.7%) | 4 | 4/580 (0.7%) | 4 | 6/574 (1%) | 6 |
| Gastrooesophageal Reflux Disease | 2/581 (0.3%) | 2 | 1/580 (0.2%) | 1 | 3/574 (0.5%) | 3 |
| Haematochezia | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Ileus | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Intestinal Obstruction Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Intestinal Perforation Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Vomiting Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| General disorders | ||||||
| Drug Withdrawal Syndrome Neonatal | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Multi-Organ Failure | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pyrexia | 5/581 (0.9%) | 5 | 5/580 (0.9%) | 5 | 1/574 (0.2%) | 1 |
| Sudden Infant Death Syndrome | 1/581 (0.2%) | 1 | 2/580 (0.3%) | 2 | 5/574 (0.9%) | 5 |
| Hepatobiliary disorders | ||||||
| Hyperbilirubinaemia | 2/581 (0.3%) | 2 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Jaundice Nos | 10/581 (1.7%) | 10 | 3/580 (0.5%) | 3 | 2/574 (0.3%) | 2 |
| Infections and infestations | ||||||
| Abscess Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Arthritis Bacterial | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Breast Abscess | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Bronchiolitis | 13/581 (2.2%) | 14 | 28/580 (4.8%) | 30 | 15/574 (2.6%) | 17 |
| Bronchitis Acute Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Bronchopneumonia Nos | 3/581 (0.5%) | 3 | 9/580 (1.6%) | 9 | 8/574 (1.4%) | 9 |
| Cellulitis | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cellulitis Gangrenous | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Conjunctivitis Infective | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Febrile Infection | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Gastroenteritis Nos | 21/581 (3.6%) | 24 | 19/580 (3.3%) | 21 | 16/574 (2.8%) | 18 |
| Gastrointestinal Infection Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Impetigo Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Lobar Pneumonia Nos | 2/581 (0.3%) | 2 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Lower Respiratory Tract Infection Nos | 3/581 (0.5%) | 3 | 2/580 (0.3%) | 2 | 0/574 (0%) | 0 |
| Mastitis | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Meningitis | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Meningitis Pneumococcal | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Neonatal Infection Nos | 5/581 (0.9%) | 5 | 1/580 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Omphalitis | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Oral Candidiasis | 3/581 (0.5%) | 3 | 1/580 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Otitis Media Acute Nos | 2/581 (0.3%) | 2 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Parainfluenzae Virus Infection Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Periorbital Cellulitis | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Pertussis | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pneumocystis Carinii Infection | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Pneumocystis Carinii Pneumonia | 3/581 (0.5%) | 3 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Pneumonia Nos | 22/581 (3.8%) | 23 | 17/580 (2.9%) | 17 | 18/574 (3.1%) | 19 |
| Pulmonary Tuberculosis | 1/581 (0.2%) | 1 | 2/580 (0.3%) | 2 | 0/574 (0%) | 0 |
| Respiratory Syncytial Virus Infection Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Respiratory Tract Infection Nos | 2/581 (0.3%) | 2 | 4/580 (0.7%) | 4 | 2/574 (0.3%) | 2 |
| Scabies Infestation | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Sepsis Neonatal | 5/581 (0.9%) | 5 | 3/580 (0.5%) | 3 | 4/574 (0.7%) | 4 |
| Sepsis Nos | 21/581 (3.6%) | 21 | 16/580 (2.8%) | 18 | 23/574 (4%) | 24 |
| Septic Shock | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Tuberculosis Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Umbilical Cord Sepsis Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Upper Respiratory Tract Infection Nos | 0/581 (0%) | 0 | 2/580 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Urinary Tract Infection Nos | 0/581 (0%) | 0 | 4/580 (0.7%) | 4 | 3/574 (0.5%) | 3 |
| Varicella | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Clavicle Fracture | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Fall | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Femur Fracture | 0/581 (0%) | 0 | 2/580 (0.3%) | 2 | 0/574 (0%) | 0 |
| Head Injury | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hypothermia | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Investigations | ||||||
| Acoustic Stimulation Tests Abnormal | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Alanine Aminotransferase Increased | 12/581 (2.1%) | 13 | 7/580 (1.2%) | 8 | 5/574 (0.9%) | 6 |
| Aspartate Aminotransferase Increased | 14/581 (2.4%) | 15 | 7/580 (1.2%) | 8 | 11/574 (1.9%) | 13 |
| Blood Calcium Increased | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Blood Creatinine Increased | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Blood Potassium Increased | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 2/574 (0.3%) | 2 |
| Blood Urea Increased | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cardiac Murmur Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| General Physical Condition Abnormal | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Weight Decreased | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 8/581 (1.4%) | 8 | 2/580 (0.3%) | 2 | 3/574 (0.5%) | 3 |
| Electrolyte Imbalance | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Failure To Thrive | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 2/574 (0.3%) | 2 |
| Feeding Problem In Newborn | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| General Nutrition Disorder | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hyperglycaemia Nos | 0/581 (0%) | 0 | 2/580 (0.3%) | 2 | 0/574 (0%) | 0 |
| Hyperkalaemia | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Hypernatraemia | 3/581 (0.5%) | 3 | 5/580 (0.9%) | 5 | 2/574 (0.3%) | 2 |
| Hypocalcaemia | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hypoglycaemia Nos | 2/581 (0.3%) | 2 | 1/580 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Hypokalaemia | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Hyponatraemia | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Malnutrition Nos | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Marasmus | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Metabolic Acidosis Nos | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Underweight | 0/581 (0%) | 0 | 2/580 (0.3%) | 2 | 0/574 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tongue Neoplasm Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Nervous system disorders | ||||||
| Cerebral Thrombosis Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Convulsions Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Encephalitis Nos | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Hydrocephalus | 1/581 (0.2%) | 2 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Poor Sucking Reflex | 2/581 (0.3%) | 2 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Visual Field Defect Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||
| Jaundice Neonatal | 10/581 (1.7%) | 10 | 3/580 (0.5%) | 3 | 6/574 (1%) | 6 |
| Premature Baby | 5/581 (0.9%) | 5 | 6/580 (1%) | 6 | 10/574 (1.7%) | 10 |
| Small For Dates Baby | 3/581 (0.5%) | 3 | 3/580 (0.5%) | 3 | 9/574 (1.6%) | 9 |
| Renal and urinary disorders | ||||||
| Renal Failure Nos | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Urinary Retention | 0/581 (0%) | 0 | 1/580 (0.2%) | 2 | 0/574 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Apnoea | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Asphyxia | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Asthma Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Bronchitis Nos | 1/581 (0.2%) | 1 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Bronchospasm Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Cough | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Cyanosis Neonatal | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Dyspnoea | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Neonatal Aspiration | 0/581 (0%) | 0 | 2/580 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Obstructive Airways Disorder Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pneumonia Aspiration | 2/581 (0.3%) | 2 | 2/580 (0.3%) | 2 | 0/574 (0%) | 0 |
| Pneumothorax Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pulmonary Artery Stenosis | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pulmonary Oedema Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Respiratory Distress | 0/581 (0%) | 0 | 4/580 (0.7%) | 5 | 3/574 (0.5%) | 3 |
| Respiratory Failure | 1/581 (0.2%) | 1 | 2/580 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Tachypnoea | 1/581 (0.2%) | 2 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Face Oedema | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Urticaria Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Social circumstances | ||||||
| Exposure To Communicable Disease | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Social Problem Nos | 12/581 (2.1%) | 12 | 14/580 (2.4%) | 14 | 24/574 (4.2%) | 24 |
| Surgical and medical procedures | ||||||
| Cardiac Operation Nos | 0/581 (0%) | 0 | 1/580 (0.2%) | 1 | 0/574 (0%) | 0 |
| Eye Excision | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension Nos | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Shock | 0/581 (0%) | 0 | 0/580 (0%) | 0 | 1/574 (0.2%) | 1 |
| Vasculitis Nos | 1/581 (0.2%) | 1 | 0/580 (0%) | 0 | 0/574 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| ARM A (ZDV Alone) | ARM B (ZDV + NVP) | ARM C (ZDV + 3TC/NFV) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 492/581 (84.7%) | 482/580 (83.1%) | 480/574 (83.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia NOS | 286/581 (49.2%) | 451 | 270/580 (46.6%) | 402 | 287/574 (50%) | 456 |
| neutropenia | 225/581 (38.7%) | 294 | 119/580 (20.5%) | 261 | 244/574 (42.5%) | 334 |
| Infections and infestations | ||||||
| oral candidiasis | 162/581 (27.9%) | 188 | 170/580 (29.3%) | 194 | 156/574 (27.2%) | 177 |
| Investigations | ||||||
| Aspartate Aminotransferase Increased | 335/581 (57.7%) | 439 | 317/580 (54.7%) | 429 | 325/574 (56.6%) | 418 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Margaret Camarca, Project Director |
|---|---|
| Organization | Westat |
| Phone | 301-517-4128 |
| margaretcamarca@westat.com |
Responsible Party:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00099359
Other Study ID Numbers:
- NICHD/HPTN 040 (P1043)
First Posted:
Dec 13, 2004
Last Update Posted:
Dec 4, 2012
Last Verified:
Feb 1, 2011