CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
ATV/r +1 moredrug
Likely dose
ATV/r 300mgfrom 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/NCT00756730
NCT00756730Phase 4Completed
CompareCT.gov

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.

Community Research Initiative of New England·interventional·Posted Sep 22, 2008·Updated Aug 21, 2017

In Brief

A Phase 4 clinical trial evaluating ATV/r and DRV/r for HIV Infections. Completed, enrolled 49 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsTibotec Pharmaceutical Limited

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2008
Enrollment StartSep 1, 2008
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.8 years ago

Interventions

ATV/rdrug

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.

DRV/rdrug

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.