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Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)

HIV Infection Clinical Trial

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

Clinical Trial Summary

Access to care and treatment using antiretroviral drugs will be expanded in Vietnam in the next few years. The ANRS 1210 study is a pilot program to evaluate the feasibility of a simplified antiretroviral treatment using three antiretroviral drugs once a day. The objectives will be to assess the efficacy and the tolerance of this treatment and to better understand the difficulties linked to social and behavioural conditions of patients at different stages during the treatment.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00158470
Study type Interventional
Source French National Agency for Research on AIDS and Viral Hepatitis
Contact
Status Completed
Phase Phase 3
Start date September 2003
Completion date May 2007
View Details
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