At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 590 enrolled

Drug / intervention

Darunavir (DRV) +1 moredrug

Likely dose

Darunavir (DRV) 100 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/NCT00524368

NCT00524368Phase 3Completed

Compare CT.gov

A Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects

Tibotec Pharmaceuticals, Ireland·interventional·Posted Sep 3, 2007·Updated Feb 15, 2013

In Brief

A Phase 3 clinical trial evaluating Darunavir (DRV) and Ritonavir (rtv) for Human Immunodeficiency Virus - Type 1. Completed, enrolled 590 participants across 85 sites in 19 countries.

Detailed Summary

The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHuman Immunodeficiency Virus - Type 1

CountriesArgentina, Australia, Austria, Brazil, Chile, France, Germany, Guatemala, Hungary, Malaysia, Panama, Puerto Rico, Romania, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedSep 2007

Enrollment StartOct 2007

Primary CompletionAug 2009

Study CompletionOct 2011

TodayJul 2026

First PostedSep 3, 2007

Enrollment StartOct 1, 2007

Primary CompletionAug 1, 2009

Study CompletionOct 1, 2011

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 18.8 years ago

Interventions

Darunavir (DRV)drug

DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.

Ritonavir (rtv)drug

DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.