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Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)

NCT00573001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-05-15

No results posted yet for this study

Summary

The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir/Emtricitabine (Truvada) and Nevirapine

Tenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days

DRUG

Tenofovir/Emtricitabine/Efavirenz (Atripla)

Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day

DRUG

Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)

Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day

DRUG

Tenofovir/Emtricitabine (Truvada) and Zidovudine

Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day

Sponsors & Collaborators

  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

    collaborator OTHER

  • Gilead Sciences

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Landman Roland, MD · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

  • Sow Papa Salif, MD · Hopital de Fann, Dakar

  • Koulla Shiro Sinata, MD · Hopital Central Yaoundé

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Cameroon
  • Senegal

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00573001 on ClinicalTrials.gov