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

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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)


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
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Allentown, Pennsylvania 18102
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Atlanta, Georgia 30341
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Bakersfield, California 93309
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Baltimore, Maryland 21201
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Bellaire, Texas 77401
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Beverly Hills, California 90211
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Buffalo, New York 14263
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28203
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Decatur, Georgia 30033
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Detroit, Michigan 48202
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El Paso, Texas 79915
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Fort Pierce, Florida 34982
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Fort Worth, Texas 76104
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Gastonia, North Carolina 28054
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Greensboro, North Carolina 27403
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Indianapolis, Indiana 46202
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Iowa City, Iowa 52242
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Las Vegas, Nevada 89102
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Newark, New Jersey 07112
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