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

• Status: Completed
• Trial end date: 2015-12-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline; Shionogi
• Treatments: Abacavir; Dideoxynucleosides; Dolutegravir; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine

Criteria

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