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

ViiV Healthcare

Status and phase: Completed; Phase 3

Conditions: Infection, Human Immunodeficiency Virus I

Treatments: Drug: Atripla placebo; Drug: Abacavir/Lamivudine Placebo; Drug: Dolutegravir placebo; Drug: Atripla; Drug: Abacavir/Lamivudine; Drug: Dolutegravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263015

114467

Details and patient eligibility

About

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.

Full description

ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects)

OR

Atripla once daily (approximately 394 subjects)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Enrollment: 844 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Screening plasma HIV-1 RNA ≥1000 c/mL
• Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
• Ability to understand and sign a written informed consent form
• Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
• Age equal to or greater than 18 years
• A negative HLAB*5701 allele assessment

Exclusion criteria

• Women who are pregnant or breastfeeding;
• Active Center for Disease and Prevention Control (CDC) Category C disease
• Hepatic impairment
• HBV co-infection
• Anticipated need for HCV therapy during the study
• Allergy or intolerance to the study drugs or their components or drugs of their class
• Malignancy within the past 5 years
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
• Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
• Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
• Primary viral resistance in the Screening result
• Verified Grade 4 laboratory abnormality
• ALT >5 xULN
• ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin);
• Estimated creatinine clearance <50 mL/min
• Recent history (≤3 months) of upper or lower gastrointestinal bleed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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844 participants in 2 patient groups

Dolutegravir (N=~394):

Experimental group

Description:

Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily

Treatment:

Drug: Dolutegravir

Drug: Atripla placebo

Drug: Abacavir/Lamivudine

Atripla (N=~394):

Active Comparator group

Description:

Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily

Treatment:

Drug: Abacavir/Lamivudine Placebo

Drug: Atripla

Drug: Dolutegravir placebo