A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants
- Conditions
- HIV InfectionsPregnancy
- Registration Number
- NCT00001135
- Brief Summary
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their infants can help reduce the chance that a mother will give HIV to her baby during delivery.
NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the infant. It is thought that even a single dose to the mother and infant may provide enough protection to the baby during the time of exposure to HIV at birth.
- Detailed Description
NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed by the mother and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or in the maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk.
Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: (1) antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all, monotherapy \[with no multi-agent therapy\] for any duration, or multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells, 200 to 399 cells, or 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. All mothers are required to incorporate zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and give ZDV to their infants as recommended. ZDV will not be provided as part of the study.
Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2009
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States