Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
Phase 4
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00466180
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day.
We hypothesized that once-daily dosing improves adherence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
- plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions
- accept adherence electronic monitoring
- written informed consent signed
Exclusion Criteria
- asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
- AST or ALT>1.25N if hepatitis virus B or C were positive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MEMS adherence by electronic devices 28-week period (randomized phase)
- Secondary Outcome Measures
Name Time Method Virologic efficacy (RNA HIV<400cp/ml) Immunologic efficacy (CD4 count cells) Tolerance (hepatic, cutaneous, ANRS safety grade scale) Pharmacokinetics (nevirapine dosages)