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

Use our guide to learn which trials are right for you!

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
sites
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Allentown, Pennsylvania 18102
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellaire, Texas 77401
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Buffalo, New York 14263
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aires, Buenos Aires
?
mi
from
Ciudad Autonoma de Buenos Aires,
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
El Paso, Texas 79915
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fort Pierce, Florida 34982
?
mi
from
Fort Pierce, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Gastonia, North Carolina 28054
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27403
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Kansas City, Missouri 64128
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Neptune, New Jersey
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
Newark, New Jersey 07112
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68131
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Savannah, Georgia 31405
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Valhalla, New York 10595
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
West Palm Beach, Florida 33409
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials