A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

• Status: Completed
• Trial end date: 2016-12-27
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline; Shionogi
• Treatments: Dolutegravir; Raltegravir Potassium; Reverse Transcriptase Inhibitors

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