A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies
- Conditions
- HIV InfectionsPregnancy
- Registration Number
- NCT00000869
- 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 babies can help reduce the chance that a mother will give HIV to her baby during delivery. This study will also test the safety of the drug and see how well it is tolerated by the mother and her baby.
Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
- Detailed Description
Nevirapine 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 suggested that nevirapine would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. In addition, nevirapine 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 nevirapine suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of nevirapine may provide a prophylactic level of nevirapine in the infant during the time of exposure to virus in the birth canal and/or maternal blood. In addition, nevirapine may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk.
Women are randomized to receive either NVP or the corresponding placebo in active labor. Women are randomized at any time after their 32nd week gestation \[AS PER AMENDMENT 1/13/98: 28th week gestation\] \[AS PER AMENDMENT 2/23/00: 20th week gestation\]. The randomization is stratified using two factors: (1) use of \[AS PER AMENDMENT 2/23/00: current or anticipated\] antiretroviral therapy during the current pregnancy (no therapy at all; monotherapy for any duration; multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells; 200 - 399 cells; 400 cells or greater). Mothers are followed on study for 4 to 6 weeks postpartum. Mothers are also encouraged to follow the regimen of zidovudine (ZDV) outlined in the Office of Public Health and Science (PHS) treatment guidelines for both themselves and their infants. Infants are administered either NVP or placebo 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 the study drug according to their randomization group regardless of whether the mother received the study drug. Infants are followed for 4 to 6 weeks, and are tested for HIV at 4 to 6 weeks, 3 months, and 6 months.
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 (72)
Univ of South Alabama
🇺🇸Mobile, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Connecticut Children's Med Ctr
🇺🇸Farmington, Connecticut, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
The Med Ctr Inc
🇺🇸Columbus, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Tulane Univ Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Univ Hosp
🇺🇸New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
🇺🇸Camden, New Jersey, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
🇺🇸New Brunswick, New Jersey, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
St Peter's Med Ctr
🇺🇸New Brunswick, New Jersey, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
Hosp of the Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Temple Univ School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Methodist Hosp Central
🇺🇸Memphis, Tennessee, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Senetara Norfolk Gen Hosp
🇺🇸Norfolk, Virginia, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States
Tacoma Gen Hosp
🇺🇸Tacoma, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
Univ of Miami / Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Washington Hosp Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Connecticut / Farmington
🇺🇸Farmington, Connecticut, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Regional Med Ctr at Memphis
🇺🇸Memphis, Tennessee, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States