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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ViiV Healthcare
With
GlaxoSmithKline
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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)
