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

27. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase III Randomized, Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

2009

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Univ of Alabama at Birmingham - Pediatric
      • Mobile, Alabama, Forenede Stater, 36604
        • Univ of South Alabama
    • California
      • La Jolla, California, Forenede Stater, 920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach, California, Forenede Stater, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, Forenede Stater, 905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Los Angeles, California, Forenede Stater, 900951752
        • UCLA Med Ctr / Pediatric
      • San Francisco, California, Forenede Stater, 94110
        • San Francisco Gen Hosp
      • San Francisco, California, Forenede Stater, 941430105
        • UCSF / Moffitt Hosp - Pediatric
    • Colorado
      • Denver, Colorado, Forenede Stater, 802181088
        • Children's Hosp of Denver
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06032
        • Univ of Connecticut / Farmington
      • Farmington, Connecticut, Forenede Stater, 060303805
        • Connecticut Children's Med Ctr
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 200102931
        • Washington Hosp Ctr
      • Washington, District of Columbia, Forenede Stater, 20060
        • Howard Univ Hosp
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33311
        • North Broward Hosp District
      • Gainesville, Florida, Forenede Stater, 32610
        • Univ of Florida Gainesville
      • Jacksonville, Florida, Forenede Stater, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, Forenede Stater, 33161
        • Univ of Miami (Pediatric)
      • Miami, Florida, Forenede Stater, 33136
        • Univ of Miami / Jackson Memorial Hosp
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Med College of Georgia
      • Columbus, Georgia, Forenede Stater, 31901
        • The Med Ctr Inc
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hosp
      • Chicago, Illinois, Forenede Stater, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, Forenede Stater, 606371470
        • Univ of Chicago Children's Hosp
      • Chicago, Illinois, Forenede Stater, 60612
        • Univ of Illinois College of Medicine / Pediatrics
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
      • New Orleans, Louisiana, Forenede Stater, 701122699
        • Tulane Univ Hosp of New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Univ Hosp
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
      • Baltimore, Maryland, Forenede Stater, 212874933
        • Johns Hopkins Hosp - Pediatric
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hosp
      • Boston, Massachusetts, Forenede Stater, 021155724
        • Children's Hosp of Boston
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston City Hosp / Pediatrics
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, Forenede Stater, 016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Children's Hosp of Michigan
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39213
        • Univ of Mississippi Med Ctr
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
      • New Brunswick, New Jersey, Forenede Stater, 089030019
        • UMDNJ - Robert Wood Johnson Med School / Pediatrics
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • St Peter's Med Ctr
      • Newark, New Jersey, Forenede Stater, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
      • Newark, New Jersey, Forenede Stater, 07103
        • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Children's Hosp at Albany Med Ctr
      • Bronx, New York, Forenede Stater, 10461
        • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
      • Bronx, New York, Forenede Stater, 10457
        • Bronx Lebanon Hosp Ctr
      • Great Neck, New York, Forenede Stater, 11021
        • North Shore Univ Hosp
      • New York, New York, Forenede Stater, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Forenede Stater, 10029
        • Metropolitan Hosp Ctr
      • New York, New York, Forenede Stater, 10032
        • Columbia Presbyterian Med Ctr
      • Rochester, New York, Forenede Stater, 146420001
        • Univ of Rochester Med Ctr
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 277103499
        • Duke Univ Med Ctr
      • Durham, North Carolina, Forenede Stater, 27710
        • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 191044318
        • Children's Hosp of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 191341095
        • Saint Christopher's Hosp for Children
      • Philadelphia, Pennsylvania, Forenede Stater, 191341095
        • Temple Univ School of Medicine
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hosp of the Univ of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 294253312
        • Med Univ of South Carolina
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 381052794
        • Saint Jude Children's Research Hosp of Memphis
      • Memphis, Tennessee, Forenede Stater, 38103
        • Regional Med Ctr at Memphis
      • Memphis, Tennessee, Forenede Stater, 381052794
        • Methodist Hosp Central
      • Nashville, Tennessee, Forenede Stater, 372322581
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Children's Med Ctr of Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Texas Children's Hosp / Baylor Univ
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hosp of the King's Daughters
      • Norfolk, Virginia, Forenede Stater, 23507
        • Senetara Norfolk Gen Hosp
      • Richmond, Virginia, Forenede Stater, 23219
        • Med College of Virginia
    • Washington
      • Seattle, Washington, Forenede Stater, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU
      • Tacoma, Washington, Forenede Stater, 98405
        • Tacoma Gen Hosp
  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Ramon Ruiz Arnau Univ Hosp / Pediatrics
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Women may be eligible for this study if they:

  • Are HIV-positive.
  • Are at least 20 weeks pregnant. (This study has been changed. Women no longer have to be 28 weeks pregnant.)
  • Have consent from the child's father (if available).
  • Are at least 13 years old (consent of parent or guardian required if under 18).

Exclusion Criteria

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Maskning: Dobbelt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Alejandro Dorenbaum
  • Studiestol: John Sullivan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studieafslutning (Faktiske)

1. maj 2001

Datoer for studieregistrering

Først indsendt

2. november 1999

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTG 316
  • 11290 (Registry Identifier: DAIDS ES Registry Number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Nevirapin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Vietnam

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner