Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00196612
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-04
• Study Completion: 2004-09
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Posted: 2005-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Virological success from W0 to W48

Secondary Outcome Measures

Name	Time	Method
Progression of HIV infection
CD4 cell count
Safety
Treatment adherence
Quality of life
Viral mutations
Therapeutic strategy failure