NCT00466180
Completed
Phase 4
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
ConditionsHIV Infections
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- University Hospital, Caen
- Enrollment
- 62
- Primary Endpoint
- MEMS adherence by electronic devices
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
MEMS adherence by electronic devices
Time Frame: 28-week period (randomized phase)
Secondary Outcomes
- Virologic efficacy (RNA HIV<400cp/ml)
- Immunologic efficacy (CD4 count cells)
- Tolerance (hepatic, cutaneous, ANRS safety grade scale)
- Pharmacokinetics (nevirapine dosages)
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