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
Beverly Hills, California 90211
21
mi
from 91732
Beverly Hills, CA
Click here to add this to my saved trials
Allentown, Pennsylvania 18102
2356
mi
from 91732
Allentown, PA
Click here to add this to my saved trials
Atlanta, Georgia 30341
1922
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30909
2053
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
Bakersfield, California 93309
106
mi
from 91732
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21201
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Bellaire, Texas 77401
1354
mi
from 91732
Bellaire, TX
Click here to add this to my saved trials
Buffalo, New York 14263
2181
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
2100
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aires, Buenos Aires
6113
mi
from 91732
Ciudad Autonoma de Buenos Aires,
Click here to add this to my saved trials
Dallas, Texas 75230
1223
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75230
1223
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Detroit, Michigan 48202
1965
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
El Paso, Texas 79915
693
mi
from 91732
El Paso, TX
Click here to add this to my saved trials
Fort Pierce, Florida 34982
2273
mi
from 91732
Fort Pierce, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
Gastonia, North Carolina 28054
2084
mi
from 91732
Gastonia, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27403
2150
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Indianapolis, Indiana 46202
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Iowa City, Iowa 52242
1528
mi
from 91732
Iowa City, IA
Click here to add this to my saved trials
Kansas City, Missouri 64128
1343
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90025
24
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
2176
mi
from 91732
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33136
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33136
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Neptune, New Jersey
2433
mi
from 91732
Neptune, NJ
Click here to add this to my saved trials
Newark, New Jersey 07112
2422
mi
from 91732
Newark, NJ
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
1161
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68131
1299
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32806
2186
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Saint Louis, Missouri 63110
1570
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84132
573
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
Savannah, Georgia 31405
2126
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
2500
mi
from 91732
Springfield, MA
Click here to add this to my saved trials
Tampa, Florida 33612
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33612
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Valhalla, New York 10595
2443
mi
from 91732
Valhalla, NY
Click here to add this to my saved trials
Washington, District of Columbia 20007
2281
mi
from 91732
Washington,
Click here to add this to my saved trials
West Palm Beach, Florida 33409
2301
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
2122
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials