Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)

NCT00495651 Phase 3 COMPLETED

The Temprano trial is based on the following assumptions: * ART initiation at CD4 counts \<800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term. * Tuberculosis and tuberculosis-related deaths are likely to represent a considerable proportion of morbidity and mortality among HIV-infected patients with high CD4 counts in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT) and early ART could enhance each others efficacy.

Details

Lead sponsor	French National Agency for Research on AIDS and Viral Hepatitis
Phase	Phase 3
Status	COMPLETED
Enrolment	2073
Start date	2008-03
Completion	2015-01

Conditions

• HIV Infections
• Tuberculosis

Interventions

• Antiretroviral medications
• Antiretroviral medications+Isoniazid prophylaxis
• Antiretroviral medications
• Antiretroviral medications+Isoniazid prophylaxis

Primary outcomes

• Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) — 30 months
  * Severe HIV-related disease are defined as AIDS-defining diseases, non-AIDS- defining malignancies, and non-AIDS-defining invasive bacterial diseases * Invasive bacterial diseases are defined as: bacteremia, or bacterial infection of any solid organ or aseptic cavity (eg: pneumonia, pleurisy, meningitis,pyomyositis, pyelonephritis, prostatitis, orchitis, epididymitis, salpingitis, endometritis, endocarditis, cholecystitis, visceral abscesses).
• prevalence of HIV resistance (ANRS12253 associated study) — 30 month after ARV initiation

Countries

Côte d’Ivoire