Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.

The trial is prolonged for a total of 48 weeks.

Inclusion criteria

• HIV infected adults
• Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
• CD4 cell count over 100/mm3
• HIV RNA below 400 copies/ml since 6 months
• Signed written informed consent

Exclusion criteria

• Previous treatment with non nucleoside analogue, ddI alone
• Pregnancy
• Alcool abuse
• Acute infection, past neurological or pancreatic disease, biological abnormalities
• Chemotherapy or immunotherapy