Efficacy and pharmacokinetics of a switch from a regimen consisting of emtricitabine, nevirapine and tenofovir to rilpivirine, emtricitabine and tenofovir in virologically suppressed HIV-1 infected patients.
- Conditions
- HIVAIDSTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-001142-18-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Able to take medication with a 500 kcal meal.
Treated with NVP, FTC, TDF for at least the last 9 months.
No history of HIV virologic failure.
The last 2 measured HIV-RNA levels in plasma were <50 copies/ml.
=6 months between the first and last plasma with <50 copies/ HIV RNA/ml.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Use of proton pump inhibitors.
Use of H2-antagonists.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method