NCT00756730

Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r

Randomized, Open-label Study of Switch From Lopinavir/Ritonavir (LPV/r) or Fosamprenavir/Ritonavir (FPV/r) to Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r) (Plus Background Nucleoside Reverse Transcriptase Inhibitors) in Patients Experiencing Triglyceride Elevations While Receiving LPV/r or FPV/r.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Community Research Initiative of New England · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.

Detailed description

This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomization for evaluation, monitoring, and lab studies.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	ATV/r	Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
DRUG	DRV/r	We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-09-22
• Last updated: 2017-08-21
• Results posted: 2012-07-13

Locations

11 sites across 1 country: United States