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

NCT00936195 | Withdrawn Phase 3 DMC

• 1 other identifier: ANRS 12200 UMA
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

HIV Infection; Pregnancy; Breastfeeding; HIV Infections

Keywords

HIV; pregnancy; breastfeeding; PMTCT; ARV treatment; treatment naive

Outcome Measures

Primary Outcomes (1)

• 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

  at 6 and 12 months following delivery/birth

Secondary Outcomes (5)

• occurence of grade 4 events in treated women, and of grade 3 or 4 events in ARV-exposed infants

  at 6 and 12 months following delivery/birth

• frequency of virological failure (>300 copies/mL) and viral resistance profile

  at 6 month and 12 months post-delivery

• frequency of premature delivery (<37 weeks) and frequency of low birth weight (<2500 g)

  at delivery/birth

• cumulative incidence of paediatric HIV infection

  at 12 months after delivery

• tolerability of the ARV combination in treated women

  at 6 and 12 months following delivery/birth

Study Arms (2)

Atripla (R)

ACTIVE COMPARATOR

Drug: Efavirenz-Tenofovir-Emtricitabine

Combivir (R) + Kaletra (R) or Aluvia (R)

ACTIVE COMPARATOR

Drug: Zidovudine-Lamivudine-Lopinavir/Ritonavir

Interventions

Efavirenz-Tenofovir-Emtricitabine DRUG

Atripla (R) : Efavirenz 600 mg - Tenofovir 300 mg - Emtricitabine 200 mg; Dosage : 1 pill/day

Atripla (R)

Zidovudine-Lamivudine-Lopinavir/Ritonavir DRUG

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

Combivir (R) + Kaletra (R) or Aluvia (R)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• HBs Ag positive

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Gilead Sciences: collaborator
• Merck Sharp & Dohme LLC: collaborator
• GlaxoSmithKline: collaborator
• Abbott: collaborator

Study Sites (2)

Programme PAC-CI, site ANRS

Abidjan, Côte d’Ivoire

Location

Center for Infectious Desease Reserach in Zambia

Lusaka, Zambia

Location

MeSH Terms

Conditions

HIV Infections; Breast Feeding

Interventions

Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Didier K Ekouevi, MD, PhD

  Programme PACCI Abidjan, Cote d'Ivoire

  STUDY CHAIR

• François Dabis, MD, PhD

  Bordeaux 2 University, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

CÔ (1); ZA (1)