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Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial (UMA)

14. februar 2012 opdateret af: French National Agency for Research on AIDS and Viral Hepatitis

Safety and Efficacy of the Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations in Pregnant and Breastfeeding Women to Prevent mother-to Child Transmission of HIV-1 o, Resource-limited Settings: A Multicentre Randomized Phase 3 Clinical Trial

To assess the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing breastfeeding.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The prevention of MTCT during pregnancy and through breastfeeding exposure remains challenging to date in most resource-limited settings. Peripartum HIV transmission is already amenable to ARV interventions. These ARV regimens, partially efficacious are insufficiently used despite their apparent simplicity. The postnatal transmission via breastfeeding remains a serious additional threat.

This is a multicentric, non-inferiority, randomized controlled trial aiming at assessing the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women (in Cote d'Ivoire an in Zambia) to prevent MTCT overall in breastfeeding population.

The fixed-dose combination of Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV or Atripla®) is a highly effective HAART combination and the simplest ARV regimen currently available in resource-limited settings and is therefore likely to become soon the lead first-line HAART regimen for adults in such settings. Its anticipated widespread prescription in women of childbearing age requires the proper documentation of its use in pregnancy and during breastfeeding.

The combination of ZDV/3TC (Combivir®) and Lopinavir/ritonavir (LPV/r) (Kaletra® or Aluvia®) is chosen as a reference regimen as it is one of the most commonly used first-line HAART for adults and the reference regimen for PMTCT in industrialised settings.

The maternal ARV regimen will be initiated as soon as possible from 20 weeks of gestation until at least the cessation of breastfeeding (with the advice to cease at six months). The decision to stop or continue the maternal ARV regimen after breastfeeding cessation will be based on the baseline maternal CD4 count and the maternal clinical stage at baseline and/or at breastfeeding cessation. A woman with a baseline CD4 <500 cells/ml will always be proposed to continue her treatment after breastfeeding cessation. A woman with a baseline CD4 count >500 will be asked to stop her treatment after breastfeeding cessation unless she has reached the WHO clinical stage IV at that time.

Infants will receive daily Zidovudine syrup from birth during the first week of life, or an updated ARV post-exposure prophylaxis recommended by WHO when women receive HAART.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Programme PAC-CI, site ANRS
  • Zambia
      • Lusaka, Zambia
        • Center for Infectious Desease Reserach in Zambia

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:

  • being pregnant, presenting in at least the 20th week of pregnancy and no later than 2 weeks before the expected term;
  • at least 18 years of age;
  • diagnosed as infected with HIV-1 only;
  • not currently taking any ARV drugs;
  • having not been exposed to NVP in the 6 months preceding enrolment;
  • willing to breastfeed their forthcoming child;
  • residing and planning to continue to reside within the predefined catchment areas until 12 months after delivery;
  • being able to give informed consent for enrolment in the study;
  • lacking any medical contraindication to any of the proposed ARV medications;
  • and accepting the principle of being randomized to receive one of the ARV regimens evaluated within the study, to prevent MTCT and for their own health when required.

Exclusion Criteria:

  • presenting within 2 weeks before the expected term;
  • currently taking ARV drugs;
  • having been exposed to NVP in the 6 months preceding enrolment;
  • not willing to breastfeed their forthcoming child;
  • having severe renal insufficiency (creatin clearance < 60ml/min);
  • diagnosed as infected with HIV-2 only or dually infected HIV-1 and HIV-2;
  • hemoglobin < 7 g/dL in the month preceding inclusion
  • HBs Ag positive

Women meeting one of the three last exclusion criteria (HIV-2 infection or co-infection, hemoglobin < 7 g/dL, HBs Ag positive) will not be randomized but will all received Atripla and be followed-up in an ancillary open cohort according the same procedures and agenda.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Atripla (R)
Medicin: Efavirenz-Tenofovir-Emtricitabine
Atripla (R) : Efavirenz 600 mg - Tenofovir 300 mg - Emtricitabine 200 mg; Dosage : 1 pill/day
Aktiv komparator: Combivir (R) + Kaletra (R) or Aluvia (R)
Medicin: Zidovudine-Lamivudine-Lopinavir/Ritonavir

Combivir (R) : Zidovudine 300 mg - Lamivudine 150 mg Dosage : 1 pill twice a day

Kaletra (R) or Aluvia (R) : Lopinavir 200 mg / Ritonavir 50 mg Dosage : 2 or 3 pills twice a day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
cumulative occurence of : -adverse pregnancy outcomes (spontaneous abortion, stillbirth, congenital abnormality requiring surgical correction in children < 1 yr of age); -paediatric HIV infection; -infant mortality
Tidsramme: at 6 and 12 months following delivery/birth
at 6 and 12 months following delivery/birth

Sekundære resultatmål

Resultatmål
Tidsramme
occurence of grade 4 events in treated women, and of grade 3 or 4 events in ARV-exposed infants
Tidsramme: at 6 and 12 months following delivery/birth
at 6 and 12 months following delivery/birth
frequency of virological failure (>300 copies/mL) and viral resistance profile
Tidsramme: at 6 month and 12 months post-delivery
at 6 month and 12 months post-delivery
frequency of premature delivery (<37 weeks) and frequency of low birth weight (<2500 g)
Tidsramme: at delivery/birth
at delivery/birth
cumulative incidence of paediatric HIV infection
Tidsramme: at 12 months after delivery
at 12 months after delivery
tolerability of the ARV combination in treated women
Tidsramme: at 6 and 12 months following delivery/birth
at 6 and 12 months following delivery/birth

Samarbejdspartnere og efterforskere

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

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Samarbejdspartnere

GlaxoSmithKline
Merck Sharp & Dohme LLC
Gilead Sciences
Abbott

Efterforskere

  • Studiestol: Didier K Ekouevi, MD, PhD, Programme PACCI Abidjan, Cote d'Ivoire
  • Studiestol: François Dabis, MD, PhD, Bordeaux 2 University, France

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. januar 2010

Primær færdiggørelse (Forventet)

1. januar 2013

Studieafslutning (Forventet)

1. juni 2013

Datoer for studieregistrering

Først indsendt

8. juli 2009

Først indsendt, der opfyldte QC-kriterier

8. juli 2009

Først opslået (Skøn)

9. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ANRS 12200 UMA

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Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Efavirenz-Tenofovir-Emtricitabine

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Placeringer

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