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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Shionogi

GlaxoSmithKline

Information provided by (Responsible Party):

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT01263015

First received: December 16, 2010

Last updated: May 29, 2014

Last verified: May 2014

History of Changes

Results First Received: August 15, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, 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
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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	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.
EFV/TDF/FTC 600/200/300 mg Once Daily	Participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg.

Participant Flow: Overall Study

	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
STARTED	414	419
Ongoing	363	335
COMPLETED	0	0
NOT COMPLETED	414	419
Adverse Event	10	42
Lack of Efficacy	14	13
Protocol Violation	7	7
Lost to Follow-up	14	9
Withdrawal by Subject	5	11
Physician Decision	1	2
Ongoing	363	335

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	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.
EFV/TDF/FTC 600/200/300 mg Once Daily	Participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg.
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
Number of Participants [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:

Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (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 data cut off for Week 48 analysis (average of 357.0 days for DTG; average of 332.2 study days for EFV/TDF/FTC) ]

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3. 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 data cut off for the Week 48 analysis (average of 357.0 study days for DTG; average of 332.2 study days for EFV/TDF/FTC) ]

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4. Secondary:

Change From Baseline in Plasma HIV-1 RNA at Weeks 4, 8, 12, 24, 32, and 48 [ Time Frame: Baseline and Weeks 4, 8, 12, 24, 32, and 48 ]

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5. Secondary:

Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48 [ Time Frame: Baseline and Week 48 ]

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6. Secondary:

Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences [ Time Frame: From Baseline until Week 48 ]

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7. Secondary:

Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities [ Time Frame: From Baseline until data cut off for the Week 48 analysis (average of 357.0 study days for DTG; average of 332.2 study days for EFV/TDF/FTC) ]

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8. Secondary:

Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) [ Time Frame: Baseline to the time of virological failure (up to Week 48) ]

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9. Secondary:

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

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Measure Type	Secondary
Measure Title	Change From Baseline in the Symptom Bother Score (SBS) at Week 4
Measure Description	The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, “I do not have this symptom”; 1, "It doesn’t bother me”; 2, “It bothers me a little”; 3, “It bothers me”; 4, "It bothers me a lot." Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS.
Time Frame	Baseline and Week 4
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Participants with missing bother item scores at Week 4 had their last observation carried forward (LOCF). Only those participants contributing to the model (i.e., without missing response variables after LOCF or covariates) were analyzed.

Reporting Groups

	Description
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	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.
EFV/TDF/FTC 600/200/300 mg Once Daily	Participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg.

Measured Values

	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Number of Participants Analyzed [units: participants]	394	393
Change From Baseline in the Symptom Bother Score (SBS) at Week 4 [units: scores on a scale] Least Squares Mean ± Standard Error	-1.818 ± 0.3849	-1.246 ± 0.3854

No statistical analysis provided for Change From Baseline in the Symptom Bother Score (SBS) at Week 4

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.

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:	May 29, 2014
Health Authority:	Spain: Agencia Espanola de Medicamentos y Productos Sanitarios Italy: Comitato Etico Fondazione Centro San Raffaele del Monte Tabor - Via Olgettina, 60 - 20132 Milano Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Belgium: Federal Agency for Medicines and Health Products, FAMHP United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Hungary: Országos Gyógyszerészeti Intézet South Africa: Medicines Control Council Germany: Bundesinstitut für Arzneimittel und Medizinprodukte Romania: National Medicines Agency Denmark: Danish Medicines Agency France: Agence Française de Sécurité Sanitaire des Produits de Santé Canada: Health Canada Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Australia: Therapeutic Goods Administration

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