Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study of a Once Daily Antiretroviral Regimen for HIV-Infected Patients With CD4 Below 200/mm3, in Hô Chi Minh City, Vietnam|
- CD4 lymphocyte count after HAART [ Time Frame: 6 months ]
- Evaluation of treatment failures causes [ Time Frame: 12 months ]
- Assessment of patients social and behavioral conditions at different stages during the treatment [ Time Frame: 12 months ]
|Study Start Date:||September 2003|
|Study Completion Date:||May 2007|
Despite a high number of infected subjects (estimated of 250,000 at the end of 2004) and a rapid spread of HIV infection in Vietnam, the use of anti-retroviral therapy remains limited. However, access to care and treatment will be expanded in Vietnam in the next few years with the support of national and international organisations. ANRS 1210 study is the first pilot program using highly active antiretroviral therapy (HAART) to evaluate the efficacy and the tolerance of an antiretroviral therapy delivered to adults in an external system of medical care, in Ho Chi Minh City. This feasibility study has also the objective to evaluate the cause of treatment failures and to assess social and behavioural conditions of patients at different stages during the treatment.
The present study is an open trial with direct individual benefit. The chosen treatment is a once-daily administration of 3TC, ddI and Efavirenz delivered to HIV infected adults with a CD4 count below 200/mm3. The duration of the study is eighteen months with a main evaluation at six months. One hundred patients will be selected in outpatient consultation of Binh Trieu hospital and Tropical Diseases Hospital of Ho Chi Minh City. The main criteria of evaluation will be the immunological response at 6 months, opportunistic infection events and the proportion of patients undergoing a regular monitoring at 6 months. Viral response will be also appreciated but, for technical question, will not be a main criteria of the study.
Patients are also administered a questionnaire by a trained independent interviewer about adherence to treatment, mental well-being, housing and nutrition, drug and sexual behaviour, social support and disclosure in order to study the associations between sociobehavioural dimensions, adherence and viral load at two successive follow-up visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158470
|Binh Trieu Hospital|
|Ho Chi Minh City, Vietnam|
|Tropical Diseases Hospital|
|Ho Chi Minh City, Vietnam|
|Study Chair:||Jean Yves Follezou, Pr||CHU Pitié-Salpêtrière, Paris, France|
|Principal Investigator:||Huu Chi Nguyen, Dr||Tropical Diseases Hospital - Ho Chi Minh City - Vietnam|