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Ensayos clínicos

Ensayos clínicos

A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000869, ACTG 316
  • Concluido

Propósito del estudio

To evaluate the effect of nevirapine (NVP) versus placebo on the incidence of HIV transmission. To evaluate the safety and tolerance of oral NVP in pregnant HIV-infected women and to HIV-exposed infants.

Afección:Fase:
Infecciones por el VIH
Embarazo
Fase 3

Detalles del estudio

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.

Criterios de exclusión

    Women will not be eligible for this study if they: Have ever taken NNRTIs (nonnucleoside reverse transcriptase inhibitors). Are enrolled in another pregnancy treatment study. Are allergic to benzodiazepines. Have liver disease. Plan to breast-feed.

Centros de estudio/contactos

Alabama

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

    Univ of South Alabama, Mobile, Alabama, 36604, United States

California

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

    Long Beach Memorial (Pediatric), Long Beach, California, 90801, United States

    Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California, 905022004, United States

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

    Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States

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

    San Francisco Gen Hosp, San Francisco, California, 94110, United States

Colorado

    Children's Hosp of Denver, Denver, Colorado, 802181088, United States

Connecticut

    Connecticut Children's Med Ctr, Farmington, Connecticut, 060303805, United States

    Univ of Connecticut / Farmington, Farmington, Connecticut, 06032, United States

District of Columbia

    Washington Hosp Ctr, Washington, District of Columbia, 200102931, United States

    Howard Univ Hosp, Washington, District of Columbia, 20060, United States

Florida

    North Broward Hosp District, Fort Lauderdale, Florida, 33311, United States

    Univ of Florida Gainesville, Gainesville, Florida, 32610, United States

    Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida, 32209, United States

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

    Univ of Miami / Jackson Memorial Hosp, Miami, Florida, 33136, United States

Georgia

    Med College of Georgia, Augusta, Georgia, 30912, United States

    The Med Ctr Inc, Columbus, Georgia, 31901, United States

Illinois

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

    Cook County Hosp, Chicago, Illinois, 60612, United States

    Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois, 60612, United States

    Univ of Chicago Children's Hosp, Chicago, Illinois, 606371470, United States

Louisiana

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

    Univ Hosp, New Orleans, Louisiana, 70112, United States

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

Maryland

    Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland, 21201, United States

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

Massachusetts

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

    Boston City Hosp / Pediatrics, Boston, Massachusetts, 02118, United States

    Brigham and Women's Hosp, Boston, Massachusetts, 02115, United States

    Baystate Med Ctr of Springfield, Springfield, Massachusetts, 01199, United States

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

Michigan

    Children's Hosp of Michigan, Detroit, Michigan, 48201, United States

Mississippi

    Univ of Mississippi Med Ctr, Jackson, Mississippi, 39213, United States

New Jersey

    Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl, Camden, New Jersey, 08103, United States

    UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey, 089030019, United States

    St Peter's Med Ctr, New Brunswick, New Jersey, 08903, United States

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

    Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey, 07103, United States

New York

    Children's Hosp at Albany Med Ctr, Albany, New York, 12208, United States

    Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York, 10461, United States

    Bronx Lebanon Hosp Ctr, Bronx, New York, 10457, United States

    North Shore Univ Hosp, Great Neck, New York, 11021, United States

    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

    Metropolitan Hosp Ctr, New York, New York, 10029, United States

    Univ of Rochester Med Ctr, Rochester, New York, 146420001, United States

    SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York, 13210, United States

North Carolina

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

    Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham, North Carolina, 27710, United States

Pennsylvania

    Temple Univ School of Medicine, Philadelphia, Pennsylvania, 191341095, United States

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

    Hosp of the Univ of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

    Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania, 191341095, United States

South Carolina

    Med Univ of South Carolina, Charleston, South Carolina, 294253312, United States

Tennessee

    Methodist Hosp Central, Memphis, Tennessee, 381052794, United States

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

    Regional Med Ctr at Memphis, Memphis, Tennessee, 38103, United States

    Vanderbilt Univ Med Ctr, Nashville, Tennessee, 372322581, United States

Texas

    Children's Med Ctr of Dallas, Dallas, Texas, 75235, United States

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

Virginia

    Children's Hosp of the King's Daughters, Norfolk, Virginia, 23507, United States

    Senetara Norfolk Gen Hosp, Norfolk, Virginia, 23507, United States

    Med College of Virginia, Richmond, Virginia, 23219, United States

Washington

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

    Tacoma Gen Hosp, Tacoma, Washington, 98405, United States

    Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon, Washington, 00956, Puerto Rico

    San Juan City Hosp, San Juan, Washington, 009367344, Puerto Rico

    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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