Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

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

Summary

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

• Phase: Phase 2
• 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 infection

• Antiretroviral naive

• CD4 cell count over 100/mm3

• Plasma HIV RNA load over 5,000 copies/mL

• Signed written informed consent

Exclusion Criteria:

• Hepatitis B infection

• Pregnancy

• Alcool abuse

• Acute infection, past neurological or pancreatic disease, biological abnormalities

• Chemotherapy or immunotherapy