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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Gilead Sciences; Merck Sharp & Dohme Corp.
• Treatments: Anti-Retroviral Agents; Isoniazid

Criteria

Inclusion Criteria:

• HIV-1 or HIV-1 + HIV-2 infection

• Age >18 years

• No ongoing active tuberculosis

• Home address in any district of the greater Abidjan area

• Written informed consent before any clinic visit or laboratory test

• Clinical and immunologic status:CD4 counts <800/mm3 and no criteria for starting ART according to the most recent WHO guidelines

Exclusion Criteria:

• Pregnant or breastfeeding women

• HIV-2 infection alone

• Clinical signs suggesting a severe disease (including tuberculosis) that has not yet been diagnosed, such as fever, wasting, diarrhea or unexplained cough (partial list)

• Previous ART initiation

• Known severe renal, cardiac or hepatic disease