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Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda

1. april 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase III Randomized Clinical Trial of the Standard Two Dose Nevirapine (NVP) Regimen With the Addition of HIV Immune Globulin(HIVIGLOB) or Extended Infant NVP Dosing Compared With the Standard NVP Regimen Alone for the Prevention of Maternal-Infant HIV Transmission in Uganda

The increase in pediatric HIV infection has a substantial impact on childhood mortality in the developing world. A number of recent studies suggest that as many as half or more of mother-to-child HIV transmissions in developing countries occur in late pregnancy or during labor and delivery. Interventions targeted during the perinatal period have shown to be effective and to have a significant impact in reducing transmission. The purpose of this study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or extended NVP dosing regimens in HIV-infected pregnant women and their infants during the perinatal period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

There is an urgent need to find safe, effective means of preventing mother-to-child-transmission (MTCT) of HIV that can be used in developing countries. One of the greatest obstacles to prevention in these areas remains HIV transmission through breast milk. The primary purpose of this trial is to determine if nevirapine (NVP) plus immunoprophylaxis (by intravenous HIV immune globulin [HIVIGLOB]) or extended NVP dosing of the neonate during the perinatal period can safely and effectively reduce the risk of peripartum or early breastfeeding-related HIV MTCT.

This study will last 11-18 weeks for each mother and 18 months for each infant. HIV-infected pregnant women will be randomly assigned to one of three arms. Participants in Arm 1 will receive a single dose of 200 mg NVP orally at the onset of labor. Infants in Arm 1 will receive a single dose of 2 mg/kg NVP orally within the first week after delivery. Arm 2 participants will receive a single dose of 200 mg NVP orally at the onset of labor. Infants in Arm 2 will receive 2 mg/kg NVP orally within the first week after delivery and 5 mg NVP taken orally daily from Day 8 through Week 6. Arm 3 participants will receive a 12 gm intravenous dose of HIVIGLOB at 36-37 weeks gestation and 200 mg NVP orally at the onset of labor. Infants in Arm 3 will receive a single 1.2 gm intravenous dose HIVIGLOB within 18 hours of birth and 2 mg/kg NVP orally within the first week after delivery.

There will be five or six study visits for pregnant participants. A targeted medical history, physical examination, and blood collection will occur at all visits. After birth, there will be 11 study visits for infants in Arms 1 and 2 and 12 study visits for infants in Arm 3. Medical history and a targeted physical exam will occur at all visits. Blood collection will occur at some visits.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

722

Fase

  • Fase 3

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:

  • Pregnant between 32-36 weeks estimated gestation
  • HIV Infected
  • Intent to breastfeed infant
  • Certain laboratory criteria. More information on this criterion can be found in the protocol.

Exclusion Criteria:

  • Sensitivity to immune globulin preparations or any benzodiazepine
  • Clinically significant disease, as determined by the investigator, that would compromise the ability of the participant to complete the study requirements
  • Currently receiving antiretroviral therapy (other than the intrapartum NVP or other peripartum regimens)
  • Participation in any HIV vaccine trials
  • History of cytotoxic chemotherapy within one month of study entry
  • Uncontrolled hypertension
  • Chronic alcohol or illicit drug use
  • History of non-compliance with visits or medication
  • Women who become pregnant again during study follow-up will not be eligible for re-enrollment in the trial

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1

Mother dosing regimen: Single dose of 200 mg NVP taken orally at onset of labor

Infant dosing regimen: Single dose of 2 mg/kg NVP taken orally within the first week after delivery
Medicin: Nevirapine
200 mg Nevirapine tablet
Andre navne:
  • NVP Viramune
Eksperimentel: 2

Mother dosing regimen: Single dose of 200 mg NVP taken orally at onset of labor

Infant dosing regimen: 2 mg/kg NVP taken orally within the first week after delivery and 5 mg NVP taken orally daily from Day 8 through Week 6
Medicin: Nevirapine
200 mg Nevirapine tablet
Andre navne:
  • NVP Viramune
Eksperimentel: 3

Mother dosing regimen: Single 12 gm intravenous dose of HIVIGLOB at 36 - 37 weeks gestation and 200 mg NVP taken orally at onset of labor

Infant dosing regimen: Single 1.2 gm intravenous dose HIVIGLOB within 18 hours of birth and 2 mg/kg NVP taken orally within the first week after delivery
Medicin: Nevirapine
200 mg Nevirapine tablet
Andre navne:
  • NVP Viramune
Medicin: HIV immune globulin solution
5% intravenous HIV immune globulin solution
Andre navne:
  • HIVIGLOB

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Rate of HIV infection in infants born to study participants in each arm of the study
Tidsramme: At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18
At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18
Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone
Tidsramme: Throughout study
Throughout study

Sekundære resultatmål

Resultatmål
Tidsramme
Rate of immunologic progression in HIV-infected infants in each arm
Tidsramme: Throughout study
Throughout study
Infant mortality
Tidsramme: Throughout study
Throughout study
Maternal plasma HIV RNA levels at delivery
Tidsramme: At Birth
At Birth
Immunologic, virologic, and pharmacologic factors
Tidsramme: Throughout study
Throughout study

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: Brooks Jackson, MD, Johns Hopkins School of Medicine

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. juli 2004

Primær færdiggørelse (Faktiske)

1. juli 2007

Studieafslutning (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først indsendt

18. marts 2008

Først indsendt, der opfyldte QC-kriterier

18. marts 2008

Først opslået (Skøn)

20. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. april 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2008

Sidst verificeret

1. marts 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01AI034235 (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

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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