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Clinical Trials and Studies

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A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plustenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

Description

This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • HIV-1 infected females (gender at birth) >=18 years of age
  • Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
  • HIV-1 infection as documented by Screening plasma HIV-1 RNA >=500 c/mL.
  • Documentation that the subject is negative for the HLA-B*5701 allele.
  • Antiretroviral-naïve (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
  • Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.

  • Women who are pregnant or breastfeeding
  • Women who plan to become pregnant during the first 48 weeks of the study
  • Any subject who has had a medical intervention for gender reassignment
  • Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease
  • Subjects with any degree of hepatic impairment
  • Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study
  • History or presence of allergy to the study drugs or their components or drugs of their class
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
  • poses a significant suicidality risk
  • History of osteoporosis with fracture or requiring pharmacologic therapy
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
  • Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses;
  • Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP)
  • Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP
  • Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result
  • Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol)
  • Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound
  • Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
  • Subject has CrCL of <50 mL/min via Cockroft-Gault method
  • Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.

Sites

  • California

    • GSK Investigational Site, Los Angeles, California, 90033
    • GSK Investigational Site, Beverly Hills, California, 90211
    • GSK Investigational Site, Los Angeles, California, 90035
    • GSK Investigational Site, Bakersfield, California, 93301
  • Nevada

    • GSK Investigational Site, Las Vegas, Nevada, 89106
  • Arizona

    • GSK Investigational Site, Phoenix, Arizona, 85015
  • Texas

    • GSK Investigational Site, El Paso, Texas, 79905
    • GSK Investigational Site, Fort Worth, Texas, 76104
    • GSK Investigational Site, Dallas, Texas, 75235
    • GSK Investigational Site, Dallas, Texas, 75246
    • GSK Investigational Site, Bellaire, Texas, 77401
  • Oklahoma

    • GSK Investigational Site, Oklahoma City, Oklahoma, 73103
  • Nebraska

    • GSK Investigational Site, Omaha, Nebraska, 68198
  • Missouri

    • GSK Investigational Site, Kansas City, Missouri, 64111
    • GSK Investigational Site, St. Louis, Missouri, 63110
  • Iowa

    • GSK Investigational Site, Iowa City, Iowa, 52242
  • Indiana

    • GSK Investigational Site, Indianapolis, Indiana, 46202
  • Georgia

    • GSK Investigational Site, Atlanta, Georgia, 30309
    • GSK Investigational Site, Decatur, Georgia, 30033
  • France

    • GSK Investigational Site, Bobigny, 93009
    • GSK Investigational Site, Paris Cedex 10, 75475
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