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

Tracking Information

First Received Date ^ICMJE

July 2, 2007

Last Updated Date

September 23, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

probability of death or first active tuberculosis, as documented by the event documentation committee [ Time Frame: 30-months ]

Change History

Complete list of historical versions of study NCT00495651 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

probability of first grade 3-4 drug-related side effect [ Time Frame: 30-months ]
probability of first WHO clinical stage 3-4 defining morbidity event [ Time Frame: 30-months ]

Descriptive Information

Brief Title ^ICMJE

Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)

Official Title ^ICMJE

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)

Brief Summary

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

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 : 30 months ; follow-up for each patient: 30 months ; total trial duration: 60 months

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

HIV Infections
Tuberculosis

Intervention ^ICMJE

Drug: Isoniazid prophylaxis
Drug: HAART

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

August 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 < 600/mm3 and WHO clinical stage 1, 2 or 3
Written Informed Consent

Exclusion Criteria:

Pregnant or breastfeeding women
Active tuberculosis
HIV-2 seropositivity alone

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Côte D'Ivoire

Administrative Information

NCT ID ^ICMJE

NCT00495651

Responsible Party

Director, ANRS

Study ID Numbers ^ICMJE

ANRS 12136 TEMPRANO

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Gilead Sciences
Merck

Investigators ^ICMJE

Principal Investigator:	Xavier Anglaret, MD, PhD	Université Bordeaux 2
Principal Investigator:	Serge Eholié, MD, MSc, Pr	CHU de Treichville, Abidjan

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP