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 |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/12/2018 |
Start Date: | August 22, 2013 |
End Date: | December 31, 2020 |
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)
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)
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.
We found this trial at
47
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials