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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.


- candidate number12146
- NTR NumberNTR3368
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2012
- Secondary IDsNL40306.078.12 CCMO
- Public TitleEfficacy 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.
- Scientific TitleEfficacy 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.
- ACRONYMRilpivirine switch study
- hypothesis1. Switching from a nevirapine based HAART regimen to a rilpivirine based HAART regimen is save in patients with undetectable plasma HIV RNA at the time of switch;
2. Nevirapine induces the CYP3A4 mediated metabolism of rilpivirine.
- Healt Condition(s) or Problem(s) studiedHIV-positive patients
- Inclusion criteria1. Able to take medication with a 500 kcal meal;
2. Treated with NVP, FTC, TDF for at least the last 9 months;
3. No history of HIV virologic failure;
4. The last 2 measured HIV-RNA levels in plasma were <50 copies/ml;
5. ≥6 months between the first and last plasma with <50 copies/ HIV RNA/ml.
- Exclusion criteria1. Use of proton pump inhibitors;
2. Use of H2-antagonists.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate31-dec-2013
- Target number of participants50
- InterventionsSwitch from nevirapine to Eviplera« (=rilpivirine, emtricitabine, tenofovir) in patients treated with nevirapine, tenofovir and emtricitabine.
- Primary outcomeNumber of subjects with HIV-1 RNA <50 c/mL at Week 12 (ITT population, snapshot analysis).
- Secondary outcome1. 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;
2. Number of subjects with HIV-1 RNA <50 c/mL at Week 24 and 48 post-switch (ITT population, snapshot analysis).
- Timepoints12, 24, 48 for HIV RNA plasma load assessment;
1, 2, 3, 4, 8 weeks for PK assessment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Bart Rijnders
- CONTACT for SCIENTIFIC QUERIES Bart Rijnders
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Giliad Sciences - International
- PublicationsN/A
- Brief summaryRationale:
Patients treated for HIV often have to switch from one antiretroviral (ARV) to another for side effects. Nevirapine (NVP) is an ARV used for the treatment of HIV infected patients. It is a strong inducer of CYP3A4. Rilpivirine (RPV) is a new ARV that has shown efficacy and excellent tolerability in 2 recent phase III clinical trials. It is also metabolised through a CYP3A4 pathway. This study will evaluate the impact of NVP CYP3A4 induction on the pharmacokinetics (PK) of RPV when patients switch from NVP to RPV. Furthermore, the safety of a switch from NVP to RPV will be evaluated.

Objective:
To evaluate the safety of a switch from NVP to RPV. To measure the impact of NVP CYP 3A4 induction on Cmin serum levels of RPV when patients switch therapy from NVP to RPV. For this goal RPV trough concentrations will be compared with the mean Cmin of 80 ng/ml observed in 2 phase III trials in which RPV 25mg qd was given to treatment na´ve HIV- 1 infected patients.

Study design:
This is a single arm intervention study.

Study population:
50 adult HIV-1 infected patients treated with NVP, emtricitabine (FTC) and tenofovir (TDF) with an undetectable HIV plasma viral load for 6 months will switch from TDF, FTC, NVP to TDF, FTC, RPV 25mg qd. This latter treatment will be given as a single tablet regimen (Eviplera«) that includes FTC, TDF and RPV.

Intervention: Switch from NVP to RPV.

Main study parameters/endpoints:
Primary endpoint: Number of subjects with HIV-1 RNA <50 c/mL at Week 12 (ITT population, snapshot analysis).
Secondary endpoint: 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. Number of subjects with HIV-1 RNA <50 c/mL at Week 24 and 48 post-switch (ITT population, snapshot analysis).
- Main changes (audit trail)
- RECORD26-mrt-2012 - 9-apr-2012


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