Status:
COMPLETED
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)
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 diso...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
499 Patients enrolled
Trial Details
Trial ID
NCT01910402
Start Date
August 22 2013
End Date
August 18 2022
Last Update
February 20 2024
Active Locations (90)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85015
2
GSK Investigational Site
Bakersfield, California, United States, 93301
3
GSK Investigational Site
Beverly Hills, California, United States, 90211
4
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20007