Phase 3
N=1,735
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Disease Transmission, Vertical · Vertical Human Immunodeficiency Virus Transmission · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00099359 ↗Enrolled (actual)
1,735
Serious AEs
39.3%
Results posted
Dec 2012
Primary outcome: Primary: Infant HIV Infection Status — 24; 11; 12 participants — p=.046
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zidovudine (Drug); Nevirapine (NVP) (Drug); Epivir (3TC) (Drug); Nelfinavir (NFV) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infant HIV Infection Status |
24; 11; 12 | .046 sig |
| PRIMARY Participants With Serious Adverse Events |
86; 59; 110 | .0001 sig |
| SECONDARY Infant HIV-1 Infection Status |
37; 28; 28 | .2432 |
| SECONDARY Participant Deaths |
11; 15; 17 | 0.49 |
| SECONDARY Clinical Covariates of HIV-1 Infection |
— | — |
| SECONDARY 3TC and NFV Pharmacokinetics |
20.7; 25.5; 4.0; 7.9 | — |
| SECONDARY Risk Factors for Perinatal HIV-1 Transmission |
12; 516; 11; 523; 24; 505 | 0.05 |
| SECONDARY NVP Pharmacokinetics |
362; 2286; 459; 76 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00099359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.