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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Didanosine; Efavirenz; Lamivudine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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