NCT00543101

Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Community Research Initiative of New England · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to determine if patients who have achieved virologic suppression (\< 400 copies/mL) on any dual PI combination, can substitute both PIs with the single boosted PI darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% \< 50 c/mL) for 24 weeks. Randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting DRV/r for a dual boosted PI combination in patients with stable virologic suppression on a regimen containing a dual boosted PI combination plus at least one additional FDA-licensed antiretroviral agent from another class. Participants will be randomized (1:1) to one of the included treatment arms.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Darunavir (DRV/r)	Switch to DRV/r at a dose of 600/100 BID for 48 weeks
DRUG	continue on current dual boosted PI	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

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-10-12
• Last updated: 2017-07-21
• Results posted: 2010-08-17

Locations

5 sites across 1 country: United States