CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 256 enrolled
Drug / intervention
darunavir (DRV, TMC114) +1 moredrug
Likely dose
darunavir (DRV, TMC114) 800 mgfrom 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/NCT00458302
NCT00458302Phase 3Completed
CompareCT.gov

A Randomised, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. vs a Triple Combination Therapy With DRV/r in HIV-1 Infected Patients With Undetectable Plasma HIV-RNA on Their Current Treatments.

Janssen-Cilag International NV·interventional·Posted Apr 10, 2007·Updated Dec 19, 2012

In Brief

A Phase 3 clinical trial evaluating darunavir (DRV, TMC114) for HIV Infections and 3 related conditions. Completed, enrolled 256 participants across 27 sites in 11 countries.

Detailed Summary

The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, AIDS Virus, Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome Virus
CountriesAustria, Belgium, Denmark, Germany, Hungary, Israel, Portugal, Russia, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2007
Enrollment StartJun 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.2 years ago

Interventions

darunavir (DRV, TMC114)drug

800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks

darunavir (DRV, TMC114)drug

800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks