CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 429 enrolled
Drug / intervention
darunavir +1 moredrug
Likely dose
darunavir 600mgfrom 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/NCT00381303
NCT00381303Phase 3Completed
CompareCT.gov

GRACE: An Open-label, Multicenter Trial to Compare the Efficacy, Safety, and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race, When Administered in Combination With an Individually Optimized Background Regimen Over a 48-week Treatment Period.

Tibotec, Inc·interventional·Posted Sep 27, 2006·Updated Apr 21, 2014

In Brief

A Phase 3 clinical trial evaluating darunavir and ritonavir for HIV and Infectious. Completed, enrolled 429 participants across 46 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Infectious
CountriesCanada, Puerto Rico, United States
CollaboratorsTibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2006
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.8 years ago

Interventions

darunavirdrug

600mg bid for 48 wks

ritonavirdrug

100mg bid for 48 wks