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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: Completed Phase 3 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permi
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 |
What the finished NCT01449929 record still lists
NCT01449929 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, above the 122-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (300% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT01449929's enrollment target sits among peer trials
488 3rd of 19 higher than 17 of 19 other Infection, Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection, Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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