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

Completed · Phase 3 · Has a placebo group

Conditions studied: Infection, Human Immunodeficiency Virus I

In brief

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.

Key facts

Study ID

NCT01227824

Run by

ViiV Healthcare

People needed

828

Starts

2010-10-19

Expected to finish

2016-12-27

Last updated by the study team

2018-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Ft. Pierce, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Hillsborough, New Jersey, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Columbia, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Darlinghurst, New South Wales, Australia
• GSK Investigational Site — Surry Hills, New South Wales, Australia
• GSK Investigational Site — Melbourne, Victoria, Australia
• GSK Investigational Site — Vancouver, British Columbia, Canada
• GSK Investigational Site — Hamilton, Ontario, Canada
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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