CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Darunavir (DRV/r) +1 moredrug
Likely dose
Not stated in 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/NCT00543101
NCT00543101Phase 4Completed
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A Randomized, Controlled Trial to Evaluate the Efficacy of Substituting Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors in Individuals With Virologic Suppression for at Least 12 Weeks

Community Research Initiative of New England·interventional·Posted Oct 12, 2007·Updated Jul 21, 2017

In Brief

A Phase 4 clinical trial evaluating Darunavir (DRV/r) and continue on current dual boosted PI for HIV Infections. Completed, enrolled 24 participants across 5 sites.

Detailed Summary

This study will evaluate patients who have achieved virologic suppression (\< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% \< 50 c/mL) for 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.7 years ago

Interventions

Darunavir (DRV/r)drug

Switch to DRV/r at a dose of 600/100 BID for 48 weeks

continue on current dual boosted PIdrug

Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (\< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks