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

Sponsor:	French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:	Gilead Sciences Merck
Information provided by (Responsible Party):	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00495651

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 III

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

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Isoniazid Ftivazide

U.S. FDA Resources

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

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:	August 2013
Estimated Primary Completion Date:	August 2013 (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 Antiretroviral 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. 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

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

Contacts

Contact: Christine Danel, MD, PHD	+225 21 75 59 63	Christine.Danel@pacci.ci
Contact: Raoul Moh, MD, MPH	+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, PHD messou_eugene@yahoo.fr
Contact +225 23 46 25 51
Principal Investigator: Eugene Messou, MD, PHD
Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine	Recruiting
Abidjan, Côte D'Ivoire
Contact: Albert Minga, MD,MPH minga.albert@yahoo.fr
Contact +225 21 35 52 78
Principal Investigator: Albert Minga, MD, MPH
Centre Intégré de Recherches Biocliniques d'Abidjan	Recruiting
Abidjan, Côte D'Ivoire
Contact: Henri Chenal, MD chenal@aviso.ci
Contact +225 21 24 09 24
Principal Investigator: Henri Chenal, MD
Service des Maladies Infectieuses et Tropicales, CHU de Treichville	Recruiting
Abidjan, Côte D'Ivoire
Contact: Emmanuel Bissagnene, MD, Pr bissagnene@yahoo.fr
Contact +225 21 24 91 22
Principal Investigator: Emmanuel Bisagnene, MD, Pr
Unité de Soins Ambulatoires et de Conseil, CHU de Treichville	Recruiting
Abidjan, Côte D'Ivoire
Contact: Serge Koulé, MD kooleyso@yahoo.fr
Contact +225 21 25 94 13
Principal Investigator: Serge Koule, MD
Centre 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
Formation Sanitaire Urbaine Anonkoua Kouté	Recruiting
Abidjan, Côte D'Ivoire
Contact: Makaila Oweyole, MD +225 01 51 06 03 omakaila@yahoo.fr
Principal Investigator: Makaila Oweyole, MD

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received:	July 2, 2007
Last Updated:	December 2, 2011
Health Authority:	Cote d'Ivoire : Ministry of Health

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

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 February 12, 2012