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Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

NCT02362503

Active Not RecruitingPhase 3

Sponsor: ViiV Healthcare

Conditions: HIV Infections

Interventions: BMS-663068, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (139)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Palm Springs, California, United States
  • San Francisco, California, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Washington D.C., District of Columbia, United States
  • Ft. Pierce, Florida, United States
  • Orlando, Florida, United States
  • West Palm Beach, Florida, United States
  • Wilton Manors, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Savannah, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Southfield, Michigan, United States
  • Hillsborough, New Jersey, United States
  • Newark, New Jersey, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • + 109 more on CT.gov