Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
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|ClinicalTrials.gov Identifier: NCT02362503|
Recruitment Status : Active, not recruiting
First Posted : February 13, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infection, Human Immunodeficiency Virus||Drug: BMS-663068 Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||March 13, 2015|
|Estimated Primary Completion Date :||April 15, 2020|
|Estimated Study Completion Date :||April 15, 2020|
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.
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.
BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362503
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|Study Director:||GSK Clinical Trials||ViiV Healthcare|