A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Abacavir; Atazanavir Sulfate; Dideoxynucleosides; Dolutegravir; Emtricitabine; Lamivudine; Ritonavir; Tenofovir

Criteria

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.