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Ensayos clínicos

Ensayos clínicos

A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001135, ACTG 316B
  • Concluido

Propósito del estudio

To evaluate the effect of nevirapine (NVP) versus NVP placebo, administered to HIV-infected pregnant women in labor and to their infants within the first 48 to 72 hours of life, on the incidence of HIV transmission.

Afección:Fase:
Infecciones por el VIH
Embarazo
Fase 3

Detalles del estudio

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.

Criterios de exclusión

    You will not be eligible for this study if: You intend to breast-feed. You are allergic to benzodiazepines (a type of tranquilizer). You have a liver disorder. You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs. You refuse to take ZDV.

Centros de estudio/contactos

Alabama

    Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama, 35233, United States

California

    UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States

    UCLA Med Ctr / Pediatric, Los Angeles, California, 900951752, United States

    UCSF / Moffitt Hosp - Pediatric, San Francisco, California, 941430105, United States

District of Columbia

    Children's Hosp of Washington DC, Washington, District of Columbia, 200102916, United States

Florida

    Univ of Miami (Pediatric), Miami, Florida, 33161, United States

Illinois

    Chicago Children's Memorial Hosp, Chicago, Illinois, 606143394, United States

Louisiana

    Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States

Maryland

    Johns Hopkins Hosp - Pediatric, Baltimore, Maryland, 212874933, United States

Massachusetts

    Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States

    Univ of Massachusetts Med School, Worcester, Massachusetts, 016550001, United States

New Jersey

    Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States

New York

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

    Columbia Presbyterian Med Ctr, New York, New York, 10032, United States

North Carolina

    Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States

Pennsylvania

    Children's Hosp of Philadelphia, Philadelphia, Pennsylvania, 191044318, United States

Tennessee

    Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee, 381052794, United States

Texas

    Texas Children's Hosp / Baylor Univ, Houston, Texas, 77030, United States

Washington

    Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States

    Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, Washington, 009365067, Puerto Rico

Actualizado: 13 de octubre del 2004

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