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
- HIV
- Registration Number
- NL-OMON26054
- Lead Sponsor
- Erasmus MC
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Able to take medication with a 500 kcal meal;
2. Treated with NVP, FTC, TDF for at least the last 9 months;
Exclusion Criteria
1. Use of proton pump inhibitors;
2. Use of H2-antagonists.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of subjects with HIV-1 RNA <50 c/mL at Week 12 (ITT population, snapshot analysis).
- Secondary Outcome Measures
Name Time Method 1. Cmin RPV levels in patients that switch from NVP to RPV at 1, 2, 4, 6, 8, 12 and 24 weeks in comparison with Cmin observed in fase III RPV trial;<br /><br>2. Number of subjects with HIV-1 RNA <50 c/mL at Week 24 and 48 post-switch (ITT population, snapshot analysis).