CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 274 enrolled
Drug / intervention
Darunavir +1 moredrug
Likely dose
Not stated in 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/NCT01448707
NCT01448707Phase 3Completed
CompareCT.gov

PROTEAse Inhibitor (DRV/Rtv) in Mono- or Triple Therapy in Suppressed HIV-1 Infected Subjects

Janssen-Cilag International NV·interventional·Posted Oct 7, 2011·Updated Nov 27, 2017

In Brief

A Phase 3 clinical trial evaluating Darunavir and Ritonavir for Human Immunodeficiency Virus (HIV) Infections and Acquired Immunodeficiency Syndrome (AIDS) Virus. Completed, enrolled 274 participants across 34 sites in 13 countries.

Detailed Summary

The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus (HIV) Infections, Acquired Immunodeficiency Syndrome (AIDS) Virus
CountriesAustria, Belgium, Denmark, France, Germany, Hungary, Ireland, Israel, Poland, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2011
Enrollment StartMar 15, 2012
Primary CompletionJun 11, 2014
Study CompletionMar 18, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.7 years ago

Interventions

Darunavirdrug

Darunavir (DRV): type = exact number, unit = mg, number = 800, form = tablet, route = oral use

Ritonavirdrug

ritonavir (rtv): type = exact number, unit = mg, number = 100, form = tablet, route = oral use