CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Darunavir(DRV) +2 moredrug
Likely dose
Darunavir(DRV) 800 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/NCT01391013
NCT01391013Phase 2Completed
CompareCT.gov

A Randomised, Controlled, Open-Label Trial to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Subjects With Undetectable Plasma HIV-1 RNA on Their Current Treatments.

Janssen-Cilag S.p.A.·interventional·Posted Jul 11, 2011·Updated Jun 27, 2013

In Brief

A Phase 2 clinical trial evaluating Darunavir(DRV), Ritonavir, and 1 other intervention for Human Immunodeficiency Virus 1. Completed, enrolled 30 participants.

Detailed Summary

The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus 1
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2011
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.0 years ago

Interventions

Darunavir(DRV)drug

Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks

Ritonavirdrug

Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks

2 nucleoside reverse transcriptase inhibitors (NRTIs)drug

2 NRTIs will be administered as per the package inserts.