Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO) (TEMPRANO)
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ClinicalTrials.gov Identifier: NCT00495651 |
Recruitment Status :
Completed
First Posted : July 3, 2007
Last Update Posted : June 3, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Drug: Antiretroviral medications Drug: Antiretroviral medications+Isoniazid prophylaxis | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2073 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO) |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: I
Standard of care
|
Drug: Antiretroviral medications
Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed. |
Experimental: II
Standard of care+Isoniazid Prophylaxis:
|
Drug: Antiretroviral medications+Isoniazid prophylaxis
|
Experimental: III
Early Antiretroviral therapy
|
Drug: Antiretroviral medications
Early ART initiation on the day of inclusion, before reaching the current WHO criteria |
Experimental: IV
Early Antiretroviral therapy + Isoniazid prophylaxis
|
Drug: Antiretroviral medications+Isoniazid prophylaxis
|
- Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) [ Time Frame: 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) [ Time Frame: 30 month after ARV initiation ]
- Grade 3 or 4 clinical events (including cardiovascular, renal and bone disease) and laboratory test results, as defined by the ANRS classification system of drug-related adverse events [ Time Frame: 30 months ]
- Tuberculosis disease or tuberculosis-related death [ Time Frame: 30 months ]
- Changes in CD4 counts [ Time Frame: 30 months ]
- Resistance to antiretroviral medications [ Time Frame: 30 months ]
- Adherence to treatment [ Time Frame: 30 months ]
- Individual socio-economic factors [ Time Frame: 30 months ]
- Quality of life [ Time Frame: 30 months ]
- Conversions and reversions of repeated QuantiFERON® TB Gold tests between inclusion and month 12 (M12)(ANRS12224 associated study) [ Time Frame: 12 months ]
- Cost-effectiveness of each trial arm in the short- and long-term [ Time Frame: 30 months ]
- Death [ Time Frame: 60 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495651
Côte D'Ivoire | |
Centre de prise en charge de personnes vivant avec le VIH la pierre angulaire | |
Abidjan, Côte D'Ivoire | |
Centre de Prise en Charge et de Formation ACONDA | |
Abidjan, Côte D'Ivoire | |
Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine | |
Abidjan, Côte D'Ivoire | |
Centre Intégré de Recherches Biocliniques d'Abidjan | |
Abidjan, Côte D'Ivoire | |
Centre médico-social El Rapha | |
Abidjan, Côte D'Ivoire | |
Formation Sanitaire Urbaine Anonkoua Kouté | |
Abidjan, Côte D'Ivoire | |
Hopital Général Felix Houphouet Boigny | |
Abidjan, Côte D'Ivoire | |
Service des Maladies Infectieuses et Tropicales, CHU de Treichville | |
Abidjan, Côte D'Ivoire | |
Unité de Soins Ambulatoires et de Conseil, CHU de Treichville | |
Abidjan, Côte D'Ivoire |
Principal Investigator: | Xavier Anglaret, MD, PhD | Université Bordeaux 2 | |
Principal Investigator: | Serge Eholié, MD, MSc, Pr | CHU de Treichville, Abidjan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00495651 |
Other Study ID Numbers: |
ANRS 12136 TEMPRANO |
First Posted: | July 3, 2007 Key Record Dates |
Last Update Posted: | June 3, 2015 |
Last Verified: | June 2015 |
HIV HAART Early Intervention Naive patients |
Tuberculosis Infections Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Isoniazid Anti-Retroviral Agents |
Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Antiviral Agents |