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NCT01263015 · ClinicalTrials.gov registry record · Phase 3
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 844
- Enrollment target
NCT01263015: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT01263015 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 844 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263015, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 844 participants
- Enrollment target
Study Summary
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.
Primary Outcome
The percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non
Interventions
- DRUG Dolutegravir
- DRUG Atripla
- DRUG Abacavir/Lamivudine
- DRUG Abacavir/Lamivudine Placebo
- DRUG Dolutegravir placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 844 participants |
| Start Date | 2011-02-01 |
| Est. Completion | 2015-12-03 |
| Phase | Phase 3 |
What the finished NCT01263015 record still lists
NCT01263015 is an interventional study that assigns participants to a tested intervention. The registered 844 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Dolutegravir is the first listed.
NCT01263015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263015 about?
NCT01263015 is a clinical study titled "A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)". The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will ...
What is the current status of trial NCT01263015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 844 participants. The study started on 2011-02-01. Estimated completion is 2015-12-03.
What interventions are being tested in trial NCT01263015?
The interventions under investigation include: Dolutegravir (DRUG), Atripla (DRUG), Abacavir/Lamivudine (DRUG), Abacavir/Lamivudine Placebo (DRUG), Dolutegravir placebo (DRUG).
Who is sponsoring clinical trial NCT01263015?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01263015's enrollment target sits among peer trials
844 391st of 2000 higher than 1,609 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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