CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
TMC310911 75 mg twice daily +5 moredrug
Likely dose
TMC310911 75 mg twice dailyfrom 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/NCT00838162
NCT00838162Phase 2Completed

A Phase IIa, Open-label, Randomized Trial in Treatment-naive HIV-1-infected Subjects to Determine the Antiviral Activity of 14 Days of Monotherapy With 4 Different Dose Regimens of TMC310911 Coadministered With Ritonavir

Tibotec Pharmaceuticals, Ireland·interventional·Posted Feb 6, 2009·Updated Jun 12, 2013

In Brief

A Phase 2 clinical trial evaluating TMC310911 75 mg twice daily, TMC310911 150 mg twice daily, and 4 other interventions for Human Immunodeficiency Virus Type 1. Completed, enrolled 33 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2009
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.4 years ago

Interventions

TMC310911 75 mg twice dailydrug

TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.

TMC310911 150 mg twice dailydrug

TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14

TMC310911 300 mg twice dailydrug

TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14

TMC310911 300 mg once dailydrug

TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14

Ritonavir 100 mg twice dailydrug

Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14

Ritonavir 100 mg once dailydrug

Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14