CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
TMC125; darunavir; ritonavirdrug
Likely dose
TMC125; darunavir; ritonavir 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00534352
NCT00534352Phase 2Completed
CompareCT.gov

A Multicenter Study to Evaluate the Pharmacokinetic Profile and Safety of TMC125 Plus Tenofovir DF/Emtricitabine All Dosed Once Daily With and Without Darunavir (PREZISTA™)/ Ritonavir Once Daily in Antiretroviral naïve HIV-1 Infected Subjects

Tibotec, Inc·interventional·Posted Sep 24, 2007·Updated Apr 16, 2015

In Brief

A Phase 2 clinical trial evaluating TMC125; darunavir; ritonavir for HIV-1 Infection. Completed, enrolled 23 participants.

Detailed Summary

The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never received ARV treatment).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
Countries--
CollaboratorsTibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.8 years ago

Interventions

TMC125; darunavir; ritonavirdrug

TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks