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Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
NCT01449929 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG dolutegravir 50 mg OAD
- DRUG darunavir 800mg OAD
- DRUG ritonavir 100mg OAD
Study Locations (20)
Florida
- GSK Investigational Site — Daytona Beach
- GSK Investigational Site — Orlando
- GSK Investigational Site — Tampa
- GSK Investigational Site — Vero Beach
Georgia
- GSK Investigational Site — Augusta
- GSK Investigational Site — Decatur
- GSK Investigational Site — Macon
- GSK Investigational Site — Savannah
District of Columbia
- GSK Investigational Site — Washington D.C.
- GSK Investigational Site — Washington D.C.
- GSK Investigational Site — Washington D.C.
California
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Los Angeles
Colorado
- GSK Investigational Site — Aurora
- GSK Investigational Site — Denver
Alabama
- GSK Investigational Site — Birmingham
Connecticut
- GSK Investigational Site — Norwalk
Massachusetts
- GSK Investigational Site — Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2011-10-31 |
| Est. Completion | 2016-12-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01449929
The ClinicalTrials.gov registry entry for NCT01449929 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 3 interventions — of which dolutegravir 50 mg OAD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01449929 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Georgia, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01449929 about?
NCT01449929 is a clinical study titled "Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects". 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 subject...
What is the current status of trial NCT01449929?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2011-10-31. Estimated completion is 2016-12-26.
What conditions does trial NCT01449929 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01449929?
The interventions under investigation include: dolutegravir 50 mg OAD (DRUG), darunavir 800mg OAD (DRUG), ritonavir 100mg OAD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01449929?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01449929 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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