CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 68 enrolled
Drug / intervention
ritonavir +5 moredrug
Likely dose
ritonavir 100 mgfrom 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/NCT00757783
NCT00757783Phase 4Completed
CompareCT.gov

A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients

Tibotec, Inc·interventional·Posted Sep 23, 2008·Updated Dec 30, 2015

In Brief

A Phase 4 clinical trial evaluating ritonavir, darunavir, and 2 other interventions for HIV. Completed, enrolled 68 participants across 15 sites.

Detailed Summary

The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a fixed-dose background regimen consisting of emtricitabine \[FTC\]/tenofovir \[TDF\] 200/300 mg once daily). This study will also evaluate the safety (adverse events), effectiveness, and tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsTibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2008
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2009
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.8 years ago

Interventions

ritonavirdrug

100 mg capsule or tablet once daily for 48 weeks

ritonavirdrug

100 mg capsule or tablet once daily for 48 weeks

darunavirdrug

800 mg tablet once daily for 48 weeks

emtricitabine [FTC]/tenofovir [TDF]drug

200/300 mg tablet once daily for 48 weeks

emtricitabine [FTC]/tenofovir [TDF]drug

200/300 mg once daily for 48 weeks

atazanavirdrug

300 mg capsule once daily for 48 weeks