|- candidate number||12146|
|- NTR Number||NTR3368|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2012|
|- Secondary IDs||NL40306.078.12 CCMO|
|- Public Title||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. |
|- Scientific Title||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. |
|- ACRONYM||Rilpivirine switch study|
|- hypothesis||1. 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) studied||HIV-positive patients|
|- 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;
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 criteria||1. Use of proton pump inhibitors;|
2. Use of H2-antagonists.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2012|
|- planned closingdate||31-dec-2013|
|- Target number of participants||50|
|- Interventions||Switch from nevirapine to Eviplera« (=rilpivirine, emtricitabine, tenofovir) in patients treated with nevirapine, tenofovir and emtricitabine.|
|- Primary outcome||Number of subjects with HIV-1 RNA <50 c/mL at Week 12 (ITT population, snapshot analysis).|
|- Secondary outcome||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;|
2. Number of subjects with HIV-1 RNA <50 c/mL at Week 24 and 48 post-switch (ITT population, snapshot analysis).
|- Timepoints||12, 24, 48 for HIV RNA plasma load assessment;|
1, 2, 3, 4, 8 weeks for PK assessment.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Bart Rijnders|
|- CONTACT for SCIENTIFIC QUERIES|| Bart Rijnders|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Giliad Sciences - International |
|- Brief summary||Rationale:|
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.
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.
This is a single arm intervention study.
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)|
|- RECORD||26-mrt-2012 - 9-apr-2012|