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Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)

Status
Completed
Phase
III
Principal Investigator(s)
Xavier Anglaret & Serge Eholié
Objective

To assess the benefits and risks of early antiretroviral therapy in HIV infected adults in Abidjan, Cote d'Ivoire

Prevention Option(s)
Treatment
Study Design
Controlled
Randomized
Open label
Arms and Assigned Interventions
Description
Standard Care: Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed.
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Description
Standard of care+Isoniazid Prophylaxis: Antiretroviral initiation at any time during the trial if at least one 2009 WHO-recommended criterion for starting ART is observed. Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion
Mode of Delivery
Tablet
ARMs
Experimental
Description
Early Antiretroviral therapy: Early ART initiation on the day of inclusion, before reaching the current WHO criteria
Mode of Delivery
Tablet
ARMs
Experimental
Description
Early Antiretroviral therapy + Isoniazid prophylaxis: Early Antiretroviral medications initiation on the day of inclusion, before reaching the current WHO criteria Isoniazid prophylaxis: 300 mg of INH once a day before breakfast for six months, starting one month after study inclusion
Mode of Delivery
Tablet
ARMs
Experimental
Trial Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Product Developers
Gilead Sciences & Merck Sharp & Dohme Corp.
March 2008
December 2014
Enrollment
2 073
18
Years
Population
Women
Men
HIV positive
Sites

Centre de Prise en Charge et de Formation ACONDA

Abidjan
Ivory Coast

Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine

Abidjan
Ivory Coast

Centre Intégré de Recherches Biocliniques d'Abidjan

Abidjan
Ivory Coast

Service des Maladies Infectieuses et Tropicales, CHU de Treichville

Abidjan
Ivory Coast

Unité de Soins Ambulatoires et de Conseil, CHU de Treichville

Abidjan
Ivory Coast

Centre de prise en charge de personnes vivant avec le VIH la pierre angulaire

Abidjan
Ivory Coast

Hopital Général Felix Houphouet Boigny

Abidjan
Ivory Coast

Formation Sanitaire Urbaine Anonkoua Kouté

Abidjan
Ivory Coast

Centre médico-social El Rapha

Abidjan
Ivory Coast