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
San Diego, California 92111
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Atlanta, Georgia 30341
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Baltimore, Maryland 21201
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Bellaire, Texas 77401
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Boston, Massachusetts 02115
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Bronx, New York 10461
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Cincinnati, Ohio 45229
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Dallas, Texas 75230
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Denver, Colorado 80206
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Fort Pierce, Florida 34982
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Hillsborough, New Jersey 08844
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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Los Angeles, California 90025
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Manhasset, New York 11030
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Neptune, New Jersey
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New Haven, Connecticut 06520
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New York, New York 10032
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Newark, New Jersey 07112
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Orlando, Florida 32806
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Palm Springs, California 92262
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Philadelphia, Pennsylvania 19104
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Sacramento, California 95815
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San Francisco, California 94115
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Savannah, Georgia 31405
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Scottsdale, Arizona 85259
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Seattle, Washington 98109
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Southfield, Michigan 48075
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Tulsa, Oklahoma 74105
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Washington, District of Columbia 20007
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West Palm Beach, Florida 33409
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Wilton Manors, Florida 33305
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