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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
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: Antiretroviral medications Drug: Antiretroviral medications+Isoniazid prophylaxis Phase 3

  Show Detailed Description

Study Design

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
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Isoniazid
U.S. FDA Resources

Arms and Interventions

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
  • 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
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
  • 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

Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. prevalence of HIV resistance (ANRS12253 associated study) [ Time Frame: 30 month after ARV initiation ]

Secondary Outcome Measures :
  1. 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 ]
  2. Tuberculosis disease or tuberculosis-related death [ Time Frame: 30 months ]
  3. Changes in CD4 counts [ Time Frame: 30 months ]
  4. Resistance to antiretroviral medications [ Time Frame: 30 months ]
  5. Adherence to treatment [ Time Frame: 30 months ]
  6. Individual socio-economic factors [ Time Frame: 30 months ]
  7. Quality of life [ Time Frame: 30 months ]
  8. Conversions and reversions of repeated QuantiFERON® TB Gold tests between inclusion and month 12 (M12)(ANRS12224 associated study) [ Time Frame: 12 months ]
  9. Cost-effectiveness of each trial arm in the short- and long-term [ Time Frame: 30 months ]
  10. Death [ Time Frame: 60 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences
Merck Sharp & Dohme Corp.
Principal Investigator: Xavier Anglaret, MD, PhD Université Bordeaux 2
Principal Investigator: Serge Eholié, MD, MSc, Pr CHU de Treichville, Abidjan
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
TEMPRANO ANRS 12136 Study Group, Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpé JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouamé A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibé B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouamé E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundzé S, Hawerlander D, Ani A, Dembélé F, Koné F, Guéhi C, Kanga C, Koule S, Séri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoué G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semdé C, Kouame A, Massumbuko JM, Chêne G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholié SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00495651     History of Changes
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

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis ):
Early Intervention
Naive patients

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents