A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women

117172

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)

2013-08-22

2015-09-22

2022-08-18

Completed

Early phase I

499

Inclusion 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. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 499, 'type': 'ACTUAL'}}

2024-02-20