Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-Infected Adults (ANRS 12136 TEMPRANO) - Full Text View

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 250-500 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

MedlinePlus related topics:

AIDS Tuberculosis

ChemIDplus related topics:

Isoniazid Ftivazide

U.S. FDA Resources

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 : a Randomized Factorial Trial (ANRS 12136 TEMPRANO)

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

probability of death or first episode of active tuberculosis [ Time Frame: 30-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

probability of first grade 3-4 drug-related side effect [ Time Frame: 30-months ] [ Designated as safety issue: Yes ]
probability of first WHO clinical stage 3-4 defining morbidity event [ Time Frame: 30-months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (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

Detailed Description:

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 : 18 months ; follow-up for each patient: 30 months ; total trial duration: 48 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 seropositivity or HIV-1+2 dual seropositivity
Age over or equal to 18 years
No history of HAART
250/mm3 < CD4 nadir < 350/mm3 and WHO clinical stage 1, or 350/mm3 < CD4 nadir < 500/mm3 and WHO clinical stage 1, 2 or 3
Written Informed Consent

Exclusion Criteria:

Pregnant or breastfeeding women
Active tuberculosis
HIV-2 seropositivity alone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495651

Contacts


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

Locations


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
	Unité de Soins Ambulatoires et de Conseil, CHU de Treichville	Recruiting
	Abidjan, Côte D'Ivoire
	Contact: Constance Kanga, MD dockanga@netcourrier.com

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

Responsible Party:	ANRS ( Director )
Study ID Numbers:	ANRS 12136 TEMPRANO
First Received:	July 2, 2007
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00495651
Health Authority:	Cote d'Ivoire : Ministry of Health

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Prophylaxis

Early HAART treatment

Naive patients

Treatment Naive

Study placed in the following topic categories:

Bacterial Infections

Virus Diseases

Gram-Positive Bacterial Infections

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Mycobacterium Infections

Tuberculosis

Retroviridae Infections

Immunologic Deficiency Syndromes

Isoniazid

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Antilipemic Agents

Infection

Actinomycetales Infections

Pharmacologic Actions

Anti-Bacterial Agents

Therapeutic Uses

Lentivirus Infections

Antitubercular Agents

Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis Gilead Sciences Merck
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00495651