HIV Infections Clinical Trial
— TEMPRANOOfficial title:
Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)
The Temprano trial is based on the following assumptions:
- ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of
severe HIV-related morbidity or death in the medium term.
- Tuberculosis and tuberculosis-related deaths are likely to represent a considerable
proportion of morbidity and mortality among HIV-infected patients with high CD4 counts
in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT)
and early ART could enhance each others efficacy.
Status | Completed |
Enrollment | 2073 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 <800/mm3 and no criteria for starting ART according to the most recent WHO guidelines 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Côte D'Ivoire | Centre de prise en charge de personnes vivant avec le VIH la pierre angulaire | Abidjan | |
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 | Centre médico-social El Rapha | Abidjan | |
Côte D'Ivoire | Formation Sanitaire Urbaine Anonkoua Kouté | Abidjan | |
Côte D'Ivoire | Hopital Général Felix Houphouet Boigny | 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 |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis | Gilead Sciences, Merck Sharp & Dohme Corp. |
Côte D'Ivoire,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) | 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 bacterial infection of any solid organ or aseptic cavity (eg: pneumonia, pleurisy, meningitis,pyomyositis, pyelonephritis, prostatitis, orchitis, epididymitis, salpingitis, endometritis, endocarditis, cholecystitis, visceral abscesses). |
30 months | Yes |
Primary | prevalence of HIV resistance (ANRS12253 associated study) | 30 month after ARV initiation | No | |
Secondary | 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 | 30 months | Yes | |
Secondary | Tuberculosis disease or tuberculosis-related death | 30 months | Yes | |
Secondary | Changes in CD4 counts | 30 months | No | |
Secondary | Resistance to antiretroviral medications | 30 months | No | |
Secondary | Adherence to treatment | 30 months | No | |
Secondary | Individual socio-economic factors | 30 months | No | |
Secondary | Quality of life | 30 months | No | |
Secondary | Conversions and reversions of repeated QuantiFERON® TB Gold tests between inclusion and month 12 (M12)(ANRS12224 associated study) | 12 months | No | |
Secondary | Cost-effectiveness of each trial arm in the short- and long-term | 30 months | No | |
Secondary | Death | 60 months | Yes |
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