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NCT01449929 · ClinicalTrials.gov registry record · Phase 3
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
A Phase 3 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
- 20
- Study locations
NCT01449929 is a Phase 3 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 488 participants, above the 122-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (300% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT01449929, a Phase 3 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 122-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (300% higher). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
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.
NCT01449929 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Georgia, District of Columbia.
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.
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).
Who is sponsoring clinical trial NCT01449929?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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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