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Active Not Recruiting NCT02362503

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

Conditions: HIV Infections

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 371
Sponsor: ViiV Healthcare

Location: GSK Investigational Site Los Angeles California

Summary

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 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02362503). StuddyBuddy aggregates publicly available trial information.