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Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02362503
First received: February 9, 2015
Last updated: September 18, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-arm Phase 3 Randomized Placebo Controlled Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • The efficacy of BMS-663068, relative to placebo, is assessed using the mean change in log10 HIV-1 RNA from Day 1(baseline) to Day 8 as determined by maximum likelihood methods. [ Time Frame: At day 8 ]
    At day 8 follow the start of Blinded BMS-663068 (or Placebo) + optimized background therapy (OBT)


Secondary Outcome Measures:
  • The proportion of subjects with HIV-1 RNA decreases from baseline that exceed 0.5 log10 c/mL and 1 log10 c/mL [ Time Frame: week 24 ]
    The proportion of subjects with HIV-1 RNA decreases from baseline that exceed 0.5 log10 c/mL and 1 log10 c/mL is determined by comparing each subject's HIV-1 RNA baseline measurement

  • The durability of response (HIV-1 RNA < 40 c/mL) at Week 24 of OBT is assessed using the FDA snapshot algorithm [ Time Frame: week 24 ]
  • The frequency of Serious Adverse Event (SAEs), Adverse Event (AEs) leading to discontinuation, and Grade 3-4 laboratory abnormalities during OBT are tabulated from Case Report Forms (CRFs) and laboratory data [ Time Frame: week 24 ]
  • Disease progression during OBT is assessed using the occurrence of new AIDS defining events (CDC Class C events) or death as tabulated from CRFs [ Time Frame: week 24 ]
  • Drug resistance is assessed through phenotypic and genotypic resistance testing of isolates from subjects identified as meeting the criteria for virologic failure [ Time Frame: week 24 ]
  • The changes in CD4+ T-cells counts and percentages, for BMS-663068 and placebo when given with failing background therapies, are determined using the mean changes from baseline (Day 1) to Day 8 [ Time Frame: week 24 ]
  • The changes from baseline in HIV-1 RNA, CD4+ cell counts, and percentage of [ Time Frame: week 24 ]

Estimated Enrollment: 260
Actual Study Start Date: March 13, 2015
Estimated Study Completion Date: April 15, 2020
Estimated Primary Completion Date: April 15, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1: BMS-663068
Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068
BMS-663068
Active Comparator: B1: Placebo + BMS-663068
Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068
BMS-663068
Other: Placebo
Placebo
Experimental: BMS-663068
BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068
BMS-663068

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02362503

  Show 157 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02362503     History of Changes
Other Study ID Numbers: 205888
AI438-047 ( Other Identifier: Bristol-Myers Squibb )
Study First Received: February 9, 2015
Last Updated: September 18, 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 21, 2017