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Daily Nevirapine to Prevent Mother to Infant Transmission of HIV (SWEN)

30. juli 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Prevention of Maternal to Infant HIV Transmission in India

Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will evaluate the safety and effectiveness of adding daily infant NVP to standard prevention measures to decrease vertical transmission of HIV.

According to current statistics from the study site, approximately 70% of the pregnant HIV infected women in this study will have begun antenatal ZDV prior to the initiation of NVP at labor. The remaining 30% of the HIV infected women enrolled in this trial will have been previously undiagnosed. These women will be diagnosed with HIV infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for HIV screening prior to delivery.

All infants will receive the standard does of NVP at 72 hours postpartum. Infants will then be randomized to receive either daily NVP and a daily multivitamin (MVI) or a daily MVI alone. Infants will take NVP/MVI or MVI alone during Weeks 2 to 6 postpartum. The primary outcome measure is infant HIV infection rates at 6 months.

Two additional related cohorts of women will be followed for comparison: 1) an equal number of HIV uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality; and 2) consenting HIV infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

770

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Indien
      • Pune, Indien
        • BJ Medical College

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria for Pregnant or Postpartum Mothers

  • HIV infected
  • Planning to breastfeed
  • Able to tolerate oral drugs and available for 12 months of postpartum follow-up

Exclusion Criteria

  • Significant physical or emotional distress
  • Infant with serious or life threatening disease or severe fetal abnormality
  • Obstetrical complications affecting maternal health
  • Prior antiretroviral drugs (except antenatal ZDV or intrapartum (NVP)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum
Medicin: Nevirapine and mulitvitamins
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
Andre navne:
  • Viramune® (Boehringer Ingelheim)
Eksperimentel: 2
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day)by mouth, from week 1 through week 6 post-partum Infants: Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
Medicin: Nevirapine and mulitvitamins
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
Andre navne:
  • Viramune® (Boehringer Ingelheim)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
HIV infection rate of infants
Tidsramme: 6 months of age
6 months of age
Safety of the regimens for HIV-infected mothers and their breast-fed infants
Tidsramme: Through 12 months post-partum
Through 12 months post-partum

Sekundære resultatmål

Resultatmål
Tidsramme
Acceptability and compliance of intervention regimens
Tidsramme: Until 6 weeks of age
Until 6 weeks of age
Time to HIV infection by treatment regimen
Tidsramme: over 12 months of age
over 12 months of age
Time to infection by infant feeding practice and time to weaning
Tidsramme: Until 12 months post-partum
Until 12 months post-partum
Maternal ZDV and NVP resistance
Tidsramme: Baseline and post-partum
Baseline and post-partum
Infant morbidity and mortality by treatment arm
Tidsramme: Until 12 months post partum
Until 12 months post partum
Infant NVP resistance by treatment arm
Tidsramme: Up to 12 months post partum
Up to 12 months post partum
Maternal NVP pharmacokinetics
Tidsramme: Up to 12 months post-partum
Up to 12 months post-partum
Infant NVP pharmacokinetics
Tidsramme: Up to 12 months post-partum
Up to 12 months post-partum

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

  • Ledende efterforsker: Robert C. Bollinger, MD, MPH, Johns Hopkins University

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

Studiestart

1. august 2002

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. september 2007

Datoer for studieregistrering

Først indsendt

23. maj 2003

Først indsendt, der opfyldte QC-kriterier

27. maj 2003

Først opslået (Skøn)

28. maj 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2008

Sidst verificeret

1. august 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5R01AI045462-04 (U.S. NIH-bevilling/kontrakt)

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 Nevirapine and mulitvitamins

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in El Salvador

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner