A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
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ClinicalTrials.gov Identifier: NCT01263015 |
Recruitment Status :
Completed
First Posted : December 20, 2010
Results First Posted : July 2, 2014
Last Update Posted : April 4, 2018
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Sponsor:
ViiV Healthcare
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Infection, Human Immunodeficiency Virus I |
Interventions |
Drug: Dolutegravir Drug: Atripla Drug: Abacavir/Lamivudine Drug: Abacavir/Lamivudine Placebo Drug: Dolutegravir placebo Drug: Atripla placebo |
Enrollment | 844 |
Participant Flow
Recruitment Details | Study consisted of 96 weeks double-blind phase, followed by a 48 week open-label phase. |
Pre-assignment Details | A total of 844 participants (par.) were randomized (1:1) to one of the two treatment arms. Of these, 833 par. received at least one dose of study medication. Of the 11 par. who were randomized but not treated with investigational product, 7 par. withdrew consent, 3 par. were randomized in error, and 1 par. was lost to follow-up. |
Arm/Group Title | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | EFV/TDF/FTC 600/200/300 mg Once Daily |
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During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. | During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. |
Period Title: Double-blind Phase: 96 Weeks Duration | ||
Started | 414 | 419 |
Completed | 342 | 310 |
Not Completed | 72 | 109 |
Reason Not Completed | ||
Adverse Event | 13 | 48 |
Lack of Efficacy | 18 | 14 |
Protocol Violation | 14 | 12 |
Lost to Follow-up | 17 | 18 |
Withdrawal by Subject | 9 | 15 |
Physician Decision | 1 | 2 |
Period Title: Open-label Phase: 48 Weeks Duration | ||
Started | 341 | 309 |
Completed | 317 | 278 |
Not Completed | 24 | 31 |
Reason Not Completed | ||
Adverse Event | 3 | 10 |
Lack of Efficacy | 7 | 2 |
Protocol Violation | 3 | 2 |
Lost to Follow-up | 8 | 8 |
Physician Decision | 0 | 2 |
Withdrawal by Subject | 3 | 7 |
Baseline Characteristics
Arm/Group Title | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | EFV/TDF/FTC 600/200/300 mg Once Daily | Total | |
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During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase. | During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase. | Total of all reporting groups | |
Overall Number of Baseline Participants | 414 | 419 | 833 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 414 participants | 419 participants | 833 participants | |
36.5 (10.74) | 36.4 (10.43) | 36.4 (10.58) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 414 participants | 419 participants | 833 participants | |
Female |
67 16.2%
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63 15.0%
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130 15.6%
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Male |
347 83.8%
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356 85.0%
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703 84.4%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 414 participants | 419 participants | 833 participants |
African American (Af Am)/African Heritage (Af Ht) | 98 | 99 | 197 | |
American Indian (AI) or Alaska Native (Nat) | 13 | 17 | 30 | |
Asian | 9 | 9 | 18 | |
White | 284 | 285 | 569 | |
Af Am/Af Ht & AI or Alaska Native | 0 | 1 | 1 | |
Af Am/Af Ht & Nat Hawaiian/other Pacific Islander | 0 | 1 | 1 | |
Af Am/Af Ht & White | 3 | 2 | 5 | |
American Indian or Alaska Native & White | 6 | 4 | 10 | |
Asian & White | 1 | 0 | 1 | |
Missing | 0 | 1 | 1 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications:
Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT01263015 |
Other Study ID Numbers: |
114467 |
First Submitted: | December 16, 2010 |
First Posted: | December 20, 2010 |
Results First Submitted: | August 15, 2013 |
Results First Posted: | July 2, 2014 |
Last Update Posted: | April 4, 2018 |