A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
Condition: Infection, Human Immunodeficiency Virus I
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: GSK1349572 (dolutegravir); raltegravir; GSK1349572 Placebo; ABC/3TC; TDF/FTC; raltegravir Placebo
Intervention description: GSK1349572 50 mg taken once daily with or without food; raltegravir 400mg taken twice daily; GSK1349572 placebo taken once daily; Abacavir/Lamivudine background therapy once daily; Tenofovir/emtricitabine background therapy once daily; raltegravir placebo taken twice daily
Intervention MeSH terms: Raltegravir Potassium; Dolutegravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 828.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: integrase inhibitor; HIV Infection; raltegravir; GSK1349572

Summary:

      The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50
      mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested
      at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI
      therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult
      subjects.
    

Eligibility 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

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding;

          -  Active Center for Disease and Prevention Control (CDC) Category C disease

          -  Moderate to severe hepatic impairment

          -  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