Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults



Status:Terminated
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/22/2018
Start Date:July 8, 2015
End Date:June 7, 2017

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

A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults

The purpose of this study is to evaluate whether the combination of BMS-955176 with
atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious,
safe, and well-tolerated in HIV-1 infected treatment experienced adults.


Inclusion Criteria:

- Men and non-pregnant women, at least 18 years of age

- Antiretroviral treatment-experienced, defined as having documented evidence of having
failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or
without documented resistance)

- CD4+ T-cell count > 50 cells/mm3

- Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV,
FC < 2.2; DTG; TDF)

Exclusion Criteria:

- Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens

- Resistance or partial resistance to any study drug determined by tests at Screening

- Historical or documented genotypic and/or phenotypic drug resistance testing showing
certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs

- Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)

- Blood tests that indicate normal liver function

- Hemoglobin < 8.0 g/dL, Platelets < 50,000 cells/mm3
We found this trial at
17
sites
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, 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
Bronx, New York 10461
?
mi
from
Bronx, NY
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
DeLand, Florida 32720
?
mi
from
DeLand, FL
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
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
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
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
Palm Springs, California 92262
?
mi
from
Palm Springs, CA
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
Tulsa, Oklahoma 74105
?
mi
from
Tulsa, OK
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