Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis

Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis
Against Tuberculosis in HIV-infected Adults (ANRS 12136
TEMPRANO)
Status: Completed
Study Phase: Phase 3
Start Date: March 2008 | Completion Date: January 2015
Condition(s): HIV Infections, Tuberculosis
Full Title of Study
Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan,
Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)
Overview
The Temprano trial is based on the following assumptions: - ART initiation at CD4
counts
Detailed Description
- The main individual benefit of very early ART initiation is likely a reduction in early
severe AIDS-defining and non-AIDS-defining morbidity. While the diseases that might
justify earlier initiation in high-income countries are generally non-infectious (nonAIDS-defining malignancies, renal diseases and cardiovascular diseases), the leading
cause of early severe AIDS-defining morbidity in sub-Saharan Africa is tuberculosis
and the main causes of severe non-AIDS-defining morbidity are non-invasive bacterial
diseases. As a result of poor access to diagnosis and care, some HIV-infected people
die from early infectious diseases before reaching current WHO criteria for starting
ART. - Although the Côte d'Ivoire National Tuberculosis Program (PNLT) does not
authorize the use of prophylaxis against tuberculosis, it has allowed the Temprano
trial to provide a six-month course of isoniazid (INH) prophylaxis to half of the study
subjects. This will allow us to (i) put early ART in perspective with a early 6-month INH
prophylaxis use, in a setting where tuberculosis is the first cause of severe HIVassociated morbidity; and (ii) to describe and assess the feasibility of a six-month
course of INH prophylaxis among patients with high CD4 counts. - Some drug
toxicities are immediate but reversible. If early ART is compared to no ART in the short
term, these toxicities may demonstrate erroneously that early ART is unfavorable. The
risks and benefits of early ART initiation should therefore be evaluated over the long
term. In the Temprano trial, we will: (i) follow patients for at least 30 months and
analyze the primary outcome at 30 months; (ii) follow some study subjects for 80
months and evaluate the evolution of the ART efficacy / toxicity ratio from month 30
to month 80 as a secondary endpoint, to inform future policies if early ART is found to
be beneficial at 30 months. Main objective: To assess the benefits and risks of starting
ART immediately and/or to receive a 6-month IPT among HIV-infected adults with CD4
counts 18 years; (iii) nadir CD4 count
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study,
Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose:
Treatment
Investigator Details
Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Collaborator: Gilead Sciences
Collaborator: Merck Sharp & Dohme Corp.
Principal Investigator: Xavier Anglaret, MD, PhD Université Bordeaux 2
Principal Investigator: Serge Eholié, MD, MSc, Pr CHU de Treichville, Abidjan
Trial Location Details
Facility: Centre de prise en charge de personnes vivant avec le VIH la pierre
angulaire Abidjan, Côte D'Ivoire
Facility: Centre de Prise en Charge et de Formation ACONDA Abidjan, Côte D'Ivoire
Facility: Centre de Suivi des donneurs de sang, Centre National de Transfusion
Sanguine Abidjan, Côte D'Ivoire
Facility: Centre Intégré de Recherches Biocliniques d'Abidjan Abidjan, Côte D'Ivoire
Facility: Centre médico-social El Rapha Abidjan, Côte D'Ivoire
Facility: Formation Sanitaire Urbaine Anonkoua Kouté Abidjan, Côte D'Ivoire
Facility: Hopital Général Felix Houphouet Boigny Abidjan, Côte D'Ivoire
Facility: Service des Maladies Infectieuses et Tropicales, CHU de Treichville Abidjan,
Côte D'Ivoire
Facility: Unité de Soins Ambulatoires et de Conseil, CHU de Treichville Abidjan, Côte
D'Ivoire
Interventions
Drug: Antiretroviral medications
Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is
observed.
Drug: Antiretroviral medications+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
Drug: Antiretroviral medications
Early ART initiation on the day of inclusion, before reaching the current WHO criteria
Drug: Antiretroviral medications+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
Information Source
ID Number: ANRS 12136 TEMPRANO
NCT Identifier: NCT00495651
Health Authority: Cote d'Ivoire : Ministry of Health
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00495651
ClinicalTrials.gov processed this data on September 29, 2016
by this site. Please see the full source link above for retrieving further details from the government database.