HIV, Adult MedDRA version: 17.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: BMS-663068
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: SUB32084
Current Sponsor code: AI438-047
Other descriptive name: BMS663068
Concentration unit: mg milligram(s)
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 760 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: ? Chronic untreated HBV (however, patients with chronic treated HBV are eligible) ? HIV-2 infection ? ALT or AST > 7 x ULN ? Alkaline Phosphatase > 5 x ULN ? Bilirubin ? 1.5 x ULN (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance;Secondary Objective: - The proportion of subjects with HIV-1 RNA decreases from baseline that exceed 0.5 log10c/mL and 1 log10 c/mL is determined -The durability of response (HIV-1 RNA < 40 c/mL) at Week 24 of OBT is assessed using the FDA snapshot algorithm -The frequency of SAEs, AEs leading to discontinuation, and Grade 3-4 laboratory abnormalities during OBT are tabulated from Case Report Forms (CRFs) and laboratory data -Disease progression during OBT is assessed is assessed using the occurrence of new AIDS defining events (CDC Class C events) or death as tabulated from CRFs -Drug resistance is assessed -The changes in CD4+ T-cells counts and percentages, for BMS-663068 and placebo are determined using the mean changes from baseline (Day 1) to Day 8. -The changes from baseline in HIV-1 RNA, CD4+ cell counts, and percentage of CD4+ T-cells, for BMS-663068 when given with OBT, are assessed using laboratory results collected through Week 24;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: At day 8 follow the start of Blinded BMS-663068 (or Placebo) + optimized background therapy (OBT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of subjects with HIV-1 RNA decreases from baseline that exceed 0.5 log10c/mL and 1 log10 c/mL is determined by comparing each subject?s HIV-1 RNA baseline measurement to their Day 8 measurement. Subjects without data at Day 8 are classified as failures -The durability of response (HIV-1 RNA < 40 c/mL) at Week 24 of OBT is assessed using the FDA snapshot algorithm -The frequency of SAEs, AEs leading to discontinuation, and Grade 3-4 laboratory abnormalities during OBT are tabulated from Case Report Forms (CRFs) and laboratory data -Disease progression during OBT is assessed is assessed using the occurrence of new AIDS defining events (CDC Class C events) or death as tabulated from CRFs -Drug resistance is assessed through phenotypic and genotypic resistance testing of isolates from subjects identified as meeting the criteria for virologic failure -The changes in CD4+ T-cells counts and percentages, for BMS-663068 and placebo are determined using the mean changes from baseline (Day 1) to Day 8. -The changes from baseline in HIV-1 RNA, CD4+ cell counts, and percentage of CD4+ T-cells, for BMS-663068 when given with OBT, are assessed using laboratory results collected through Week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed