Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)
This study is ongoing, but not recruiting participants.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:
Gilead Sciences
Merck
Information provided by (Responsible Party):
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 )
ClinicalTrials.gov Identifier:
NCT00495651
First received: July 2, 2007
Last updated: October 19, 2012
Last verified: October 2012
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Purpose
Objective: To compare the benefits and risks of initiating ART according to the WHO guidelines to the benefits and risks of initiating ART immediately among HIV-infected adults with CD4 counts >350mm3 in Côte d'Ivoire, West Africa
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Antiretroviral medications Drug: Antiretroviral medications+Isoniazid prophylaxis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Isoniazid
U.S. FDA Resources
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Tuberculosis disease or tuberculosis-related death [ Time Frame: 30-months ] [ Designated as safety issue: Yes ]
- Changes in CD4 counts [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Resistance to antiretroviral medications [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Adherence to treatment [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Individual socio-economic factors [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Conversions and reversions of repeated QuantiFERON® TB Gold tests between inclusion and month 12 (M12)(ANRS12224 associated study) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Cost-effectiveness of each trial arm in the short- and long-term [ Time Frame: 30 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1642 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: I
Standard of care
|
Drug: Antiretroviral medications
Antiretroviral medications initiation at any time during the trial if at least one 2009 WHO-recommended criterion is observed: (1) two consecutive CD4 counts <350/mm3, regardless of WHO stage; or (2) WHO stage 4 disease.
|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 350-800/mm3 and WHO stage 1,2,or 3
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495651
Locations
| 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 | |
| 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 | |
| Centre de prise en charge de personnes vivant avec le VIH la pierre angulaire | |
| Abidjan, Côte D'Ivoire | |
| Hopital Général Felix Houphouet Boigny | |
| Abidjan, Côte D'Ivoire | |
| Formation Sanitaire Urbaine Anonkoua Kouté | |
| Abidjan, Côte D'Ivoire | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences
Merck
Investigators
| Principal Investigator: | Xavier Anglaret, MD, PhD | Université Bordeaux 2 |
| Principal Investigator: | Serge Eholié, MD, MSc, Pr | CHU de Treichville, Abidjan |
More Information
Additional Information:
No publications provided
| Responsible Party: | 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 ) |
| ClinicalTrials.gov Identifier: | NCT00495651 History of Changes |
| Other Study ID Numbers: | ANRS 12136 TEMPRANO |
| Study First Received: | July 2, 2007 |
| Last Updated: | October 19, 2012 |
| Health Authority: | Cote d'Ivoire : Ministry of Health |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
HIV HAART Early Intervention Naive patients |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Isoniazid Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents |
ClinicalTrials.gov processed this record on March 03, 2013
