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| Sponsor: | French National Agency for Research on AIDS and Viral Hepatitis |
|---|---|
| Collaborators: |
Gilead Sciences Merck |
| Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00495651 |
Purpose
In sub-Saharan African adults who start antiretroviral treatment following WHO 2006 guidelines, significant rates of severe morbidity - mostly tuberculosis - continue to be recorded. Patients on antiretroviral treatment who experience severe morbidity episodes have higher rates of treatment failure than other patients.
This trial aims to assess the benefits and risks of two interventions in HIV-infected adults with 250-600 CD4/mm3 and no clinical criteria for starting antiretroviral treatment according to WHO 2006 guidelines : (i) immediate 6-months tuberculosis prophylaxis, and/or (ii) immediate antiretroviral treatment initiation
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Isoniazid prophylaxis Drug: HAART |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Benefits and Risks of Early Antiretroviral Treatment Initiation and 6-months Isoniazid Prophylaxis in HIV-infected West African Adults With CD4 Count Between 250 and 600/mm3: a Randomized Factorial Trial (ANRS 12136 TEMPRANO) |
| Estimated Enrollment: | 2000 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| I: Active Comparator |
Drug: HAART
Initiation following WHO 2006 guidelines criteria ie : (i) CD4 < 200/mm3, or (ii) WHO stage 4, or (iii) WHO stage 2 or 3 and 200/mm3 < CD4 nadir < 350/mm3
|
| II: Experimental |
Drug: Isoniazid prophylaxis
300 mg Isoniazid once a day during 6 months
Drug: HAART
Initiation following WHO 2006 guidelines criteria ie : (i) CD4 < 200/mm3, or (ii) WHO stage 4, or (iii) WHO stage 2 or 3 and 200/mm3 < CD4 nadir < 350/mm3
|
| III: Experimental |
Drug: HAART
Immediate HAART initiation
|
| IV: Experimental |
Drug: Isoniazid prophylaxis
300 mg Isoniazid once a day during 6 months
Drug: HAART
Immediate HAART initiation
|
Design : Multicentric 2 x 2 factorial randomised controlled trial.
Analysis: arms will be compared 2 x 2 using time-to-failure methods. Interactions will be tested.
Timing : inclusion : 30 months ; follow-up for each patient: 30 months ; total trial duration: 60 months
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christine Danel, MD, MPH | +225 21 75 59 63 | Christine.Danel@pacci.ci |
| Contact: Raoul Moh, MD | +225 21 75 59 60 | raoul.moh@pacci.ci |
| Côte D'Ivoire | |
| Centre de Prise en Charge et de Formation ACONDA | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Eugène Messou, MD, MPH messou_eugene@yahoo.fr | |
| Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Albert Minga, MD minga.albert@caramail.com | |
| Centre Intégré de Recherches Biocliniques d'Abidjan | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Henri Chenal, MD cirba@aviso.ci | |
| Service des Maladies Infectieuses et Tropicales, CHU de Treichville | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Emmanuel Bissagnene, MD, Pr bissagnene@yahoo.fr | |
| Formation Sanitaire Urbaine Anonkoua Koulé | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Makaila Oweyole, MD +225 01 51 06 03 omakaila@yahoo.fr | |
| Principal Investigator: Makaila Oweyole, MD | |
| CEnte de prise en charge de personnes vivant avec le VIH la pierre angulaire | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Madeleine Sassan Morokro, MD +225 21 35 09 68 sassan@aviso.ci | |
| Principal Investigator: Madeleine Sassan Morokro, MD | |
| Hopital Général Felix Houphouet Boigny | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Emmanuel Kouamé, MD +225 07 07 31 64 kenkouamem@yahoo.fr | |
| Principal Investigator: Emmanuel Kouame, MD | |
| Unité de Soins Ambulatoires et de Conseil, CHU de Treichville | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Constance Kanga, MD dockanga@netcourrier.com | |
| Principal Investigator: | Xavier Anglaret, MD, PhD | Université Bordeaux 2 |
| Principal Investigator: | Serge Eholié, MD, MSc, Pr | CHU de Treichville, Abidjan |
More Information
| Responsible Party: | ANRS ( Director ) |
| Study ID Numbers: | ANRS 12136 TEMPRANO |
| Study First Received: | July 2, 2007 |
| Last Updated: | September 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00495651 History of Changes |
| Health Authority: | Cote d'Ivoire : Ministry of Health |
|
Prophylaxis Early HAART treatment Naive patients Treatment Naive |
|
Bacterial Infections Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Gram-Positive Bacterial Infections Therapeutic Uses Tuberculosis Retroviridae Infections Isoniazid RNA Virus Infections |
Immune System Diseases Antilipemic Agents Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Antitubercular Agents Fatty Acid Synthesis Inhibitors |
