A pilot study on the efficacy and pharmacokinetics of a switch from nevirapine with emtricitabine, tenofovir or lamivudine, tenofovir or lamivudine, zidovudine to rilpivirine with emtricitabine, tenofovir in virologically suppressed HIV-1 infected patients.
Recruiting
- Conditions
- HIV AIDS1002146010047438
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Able to take medication with a 500 kcal meal
Treated with NVP and FTC, TDF or 3TC, TDF or 3TC, ZDV 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
Exclusion Criteria
Use of proton pump inhibitors.
Use of H2-antagonists
Use of other contraindicated concurrent medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of subjects with HIV-1 RNA <50 c/mL at week 12 post-switch (ITT<br /><br>population, snapshot analysis)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparison of serum Cmin of RPV at 1, 2, 3, 4, 8, and 24 weeks in subset of 20<br /><br>patients with Cmin at these timepoints in phase III studies.<br /><br><br /><br>Percentage of subjects with HIV-1 RNA <50 c/mL at Week 24 post-switch (ITT<br /><br>population, snapshot analysis)<br /><br><br /><br>Percentage of subjects with HIV-1 RNA <50 c/mL at Week 48 post-switch (ITT<br /><br>population, snapshot analysis)<br /><br><br /><br>Questionnaire on satisfaction with treatment at 48 weeks in comparison with<br /><br>baseline.</p><br>