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Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects

NCT01449929 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2018-01-16

Study results available
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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.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

dolutegravir 50 mg OAD

1 x 50 mg tablet OAD

DRUG

darunavir 800mg OAD

2 x 400mg tablets OAD

DRUG

ritonavir 100mg OAD

1 x 100mg tablet OAD

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-04-22
Completion
2016-12-26
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Puerto Rico
  • Romania
  • Russia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01449929 on ClinicalTrials.gov