Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.

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

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Bristol-Myers Squibb; Dupont Applied Biosciences; Gilead Sciences; Triangle Pharmaceuticals
• Treatments: Didanosine; Efavirenz; Emtricitabine

Criteria

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