CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 488 enrolled
Drug / intervention
dolutegravir 50 mg OAD +2 moredrug
Likely dose
dolutegravir 50 mg OADfrom 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/NCT01449929
NCT01449929Phase 3Completed
CompareCT.gov

A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects

ViiV Healthcare·interventional·Posted Oct 10, 2011·Updated Jan 16, 2018

In Brief

A Phase 3 clinical trial evaluating dolutegravir 50 mg OAD, darunavir 800mg OAD, and 1 other intervention for Infection, Human Immunodeficiency Virus. Completed, enrolled 488 participants across 66 sites in 9 countries.

Detailed Summary

This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus
CountriesFrance, Germany, Italy, Puerto Rico, Romania, Russia, Spain, Switzerland, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2011
Enrollment StartOct 31, 2011
Primary CompletionApr 22, 2013
Study CompletionDec 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.7 years ago

Interventions

dolutegravir 50 mg OADdrug

1 x 50 mg tablet OAD

darunavir 800mg OADdrug

2 x 400mg tablets OAD

ritonavir 100mg OADdrug

1 x 100mg tablet OAD