Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:February 23, 2015
End Date:April 15, 2020

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A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068)
is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug
resistance.


Inclusion Criteria:

- Men and non-pregnant women with chronic HIV-1 infection

- Antiretroviral-experienced with documented historical or baseline resistance,
intolerability, and/or contraindications to antiretrovirals in at least three classes

- Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL
(first value from Investigator, second from Screening labs)

- Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals
remaining which can be effectively combined to form a viable new regimen, based on
current and/or documented historical resistance testing and tolerability and safety

- Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9
onwards in the Randomized Cohort

- Subjects without any remaining fully active approved antiretroviral may be enrolled in
the Non-Randomized Cohort

Exclusion Criteria:

- Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV
are eligible)

- HIV-2 infection

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN

- Alkaline Phosphatase > 5 x ULN

- Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on
atazanavir and has predominantly unconjugated hyperbilirubinemia)
We found this trial at
36
sites
Los Angeles, California 90025
1179
mi
from
Los Angeles, CA
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Atlanta, Georgia 30341
801
mi
from
Atlanta, GA
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Baltimore, Maryland 21201
1148
mi
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Baltimore, MD
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Bellaire, Texas 77401
572
mi
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Bellaire, TX
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Boston, Massachusetts 02115
1444
mi
from
Boston, MA
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Bronx, New York 10461
1295
mi
from
Bronx, NY
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Chapel Hill, North Carolina 27599
1043
mi
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Chapel Hill, NC
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Charlotte, North Carolina 28203
957
mi
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Charlotte, NC
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Chicago, Illinois 60611
611
mi
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Chicago, IL
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Ciudad Autonoma de Buenos Aires, Buenos Aires
5602
mi
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Ciudad Autonoma de Buenos Aires,
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Dallas, Texas 75230
340
mi
from
Dallas, TX
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Denver, Colorado 80206
407
mi
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Denver, CO
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Fort Pierce, Florida 34982
1243
mi
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Fort Pierce, FL
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Hillsborough, New Jersey 08844
1252
mi
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Hillsborough, NJ
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Houston, Texas 77030
572
mi
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Houston, TX
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Indianapolis, Indiana 46202
643
mi
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Indianapolis, IN
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Manhasset, New York 11030
1302
mi
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Manhasset, NY
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Neptune, New Jersey
1285
mi
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Neptune, NJ
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New Haven, Connecticut 06520
1344
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New Haven, CT
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New York, New York 10032
1290
mi
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New York, NY
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Newark, New Jersey 07112
1276
mi
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Newark, NJ
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Orlando, Florida 32806
1144
mi
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Orlando, FL
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Palm Springs, California 92262
1082
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Palm Springs, CA
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Philadelphia, Pennsylvania 19104
1223
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Philadelphia, PA
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Sacramento, California 95815
1280
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Sacramento, CA
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San Diego, California 92111
1139
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San Diego, CA
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San Francisco, California 94115
1340
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San Francisco, CA
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Savannah, Georgia 31405
1020
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Savannah, GA
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Scottsdale, Arizona 85259
834
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Scottsdale, AZ
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Seattle, Washington 98109
1411
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Seattle, WA
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Southfield, Michigan 48075
835
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Southfield, MI
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Tulsa, Oklahoma 74105
152
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Tulsa, OK
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Washington, District of Columbia 20007
1127
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Washington,
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West Palm Beach, Florida 33409
1282
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West Palm Beach, FL
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Wilton Manors, Florida 33305
1305
mi
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Wilton Manors, FL
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