We're sorry, but this trial is no longer enrolling volunteers.
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
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 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.
- 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
- GSK Investigational Site, Las Vegas, Nevada, 89106
- GSK Investigational Site, Phoenix, Arizona, 85015
- 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
- GSK Investigational Site, Oklahoma City, Oklahoma, 73103
- GSK Investigational Site, Omaha, Nebraska, 68198
- GSK Investigational Site, Kansas City, Missouri, 64111
- GSK Investigational Site, St. Louis, Missouri, 63110
- GSK Investigational Site, Iowa City, Iowa, 52242
- GSK Investigational Site, Indianapolis, Indiana, 46202
- GSK Investigational Site, Atlanta, Georgia, 30309
- GSK Investigational Site, Decatur, Georgia, 30033
- GSK Investigational Site, Bobigny, 93009
- GSK Investigational Site, Paris Cedex 10, 75475