Status:
COMPLETED
Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 antiretrov...
Detailed 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...
Eligibility Criteria
Inclusion
- Man or woman over 18 years old
- HIV infected
- Written informed consent signed
- CD4 count lower than 200/mm3
- No previous antiretroviral treatment
- Weight over 45 kilos and/or body mass index over 16
- Karnofsky Index over or equal to 70 percent
Exclusion
- Pregnant woman or woman without effective contraception
- Opportunistic infection compromising the realisation of the treatment
- Tumoral pathology
- Progressive psychiatric affection
- Previous history of peripheral neuropathy or pancreatitis
- Hemoglobin above 90 g/l
- PMN neutrophil above 1.0G/l
- Platelets above 50G/l
- Liver enzymes over 5 times the normal values
- Lipase and/or amylase over 2 times the normal values
- Prothrombin rate above 50 percent
- Plasmatic creatinine over 200 micromoles/l
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00158470
Start Date
September 1 2003
End Date
May 1 2007
Last Update
July 3 2007
Active Locations (2)
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1
Binh Trieu Hospital
Ho Chi Minh City, Vietnam
2
Tropical Diseases Hospital
Ho Chi Minh City, Vietnam