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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 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 844 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01263015
The ClinicalTrials.gov registry entry for NCT01263015 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 844 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dolutegravir is the first listed.
NCT01263015 reports 0 study locations.
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.
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