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

NCT00495651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2073

Last updated 2015-06-03

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Xavier Anglaret, MD, PhD · Université Bordeaux 2

  • Serge Eholié, MD, MSc, Pr · CHU de Treichville, Abidjan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Côte d’Ivoire

Study Locations

More Related Trials

Entities

Diseases
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 NCT00495651 on ClinicalTrials.gov