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UBMD Physicians' Group

Clinical Trials

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

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)

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)

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

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.

Investigator

Alyssa Shon, MD

Contact Information

Name: Alyssa Shon, MD
Phone: 898-4119
Email: alyssash@buffalo.edu