A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

This study has been completed.

Sponsor:

Collaborators:

Shionogi

GlaxoSmithKline

Information provided by (Responsible Party):

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT01263015

First received: December 16, 2010

Last updated: September 23, 2016

Last verified: September 2016

History of Changes

Results First Received: August 15, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study consisted of 96 weeks double-blind phase, followed by a 48 week open-label phase.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	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.
EFV/TDF/FTC 600/200/300 mg Once Daily	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.

Participant Flow for 2 periods

Period 1: Double-blind Phase: 96 Weeks Duration

	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
STARTED	414	419
COMPLETED	342	310
NOT COMPLETED	72	109
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 2: Open-label Phase: 48 Weeks Duration

	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
STARTED	341	309
COMPLETED	317	278
NOT COMPLETED	24	31
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

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Population Description

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Reporting Groups

	Description
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	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.
EFV/TDF/FTC 600/200/300 mg Once Daily	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	Total of all reporting groups

Baseline Measures

	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily	Total
Overall Participants Analyzed [Units: Participants]	414	419	833

Age [Units: Years] Mean (Standard Deviation)	36.5 (10.74)	36.4 (10.43)	36.4 (10.58)

Gender [Units: Participants]
Female	67	63	130
Male	347	356	703

Race/Ethnicity, Customized [Units: 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

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1. Primary:

Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 [ Time Frame: Week 48 ]

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2. Secondary:

Time to Viral Suppression (<50 c/mL) [ Time Frame: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC) ]

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3. Secondary:

Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 [ Time Frame: Week 96 and Week 144 ]

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4. Secondary:

Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24 [ Time Frame: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC) ]

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5. Secondary:

Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144 [ Time Frame: Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 ]

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6. Secondary:

Change From Baseline in CD4+ Cell Counts at Week 144 [ Time Frame: Baseline and Week 144 ]

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7. Secondary:

Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 [ Time Frame: Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 ]

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8. Secondary:

Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144 [ Time Frame: From Baseline until Week 144 ]

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9. Secondary:

Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144 [ Time Frame: From Baseline until Week 144 ]

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10. Secondary:

Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144 [ Time Frame: Through Week 144 ]

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11. Secondary:

Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48 [ Time Frame: Baseline and Week 4 through 48 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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More Information

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Certain Agreements:

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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):

Walmsley S, Baumgarten A, Berenguer J, Felizarta F, Florence E, Khuong-Josses MA, Kilby JM, Lutz T, Podzamczer D, Portilla J, Roth N, Wong D, Granier C, Wynne B, Pappa K. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790. Erratum in: J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33.

Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT01263015 History of Changes
Other Study ID Numbers:	114467
Study First Received:	December 16, 2010
Results First Received:	August 15, 2013
Last Updated:	September 23, 2016

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