AI438-047: Attachment inhibitor study in HTE patients with MDR HIV-1
Research type
Research Study
Full 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
IRAS ID
176955
Contact name
Anton Pozniak
Contact email
Sponsor organisation
ViiV Healthcare
Eudract number
2014-002111-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
73,916, IND number
Duration of Study in the UK
2 years, 0 months, 23 days
Research summary
Bristol-Myers Squibb is developing BMS-663068 (the study drug) for Human Immunodeficiency Virus Type1 (HIV1) infected Heavily Treatment Experienced (HTE) patients. Use of combination antiretroviral therapy (ARV) has significantly decreased the number of deaths from AIDS (Acquired Immunodeficiency Syndrome). Therefore, the number HIV-1 patients has increased, and HIV-1 is now considered a chronic disease requiring life-long therapy. 5% of the approximately 40 million HIV-1 patients worldwide are HTE and their treatment regime (combination of ARV) is highly individualized following multiple treatment failures. This failure is due to complex combinations of drugs, drug side effects and eventual resistance to these drug classes (drugs grouped by how they work).
BMS- 663068 belongs to a new class of investigational drugs, HIV-1 attachment inhibitors, which work in a different way to the currently marked drugs. The theory is HIV-1 attachment inhibitors block the binding of HIV-1 virus to its host cell, so the virus cannot enter the host cell and cannot produce new viruses.
The purpose of this study is to evaluate BMS-663068 (600 mg oral tablet twice daily) compared to placebo when given in combination with a failing background regimen (combination of ARV) over 8 days. Secondly, the study evaluates the response durability of BMS-663068 when given with an optimized background therapy over 24 weeks.
Additionally, the study evaluates the safety and tolerability of BMS-663068; HIV-1/AIDS disease progression and disease specific quality of life; biomarkers in the blood (specific proteins that help predict drug efficacy); how the body processes and responds to BMS-663068 (by pharmacokinetics testing); and lastly how the virus may change in response to the drug (by HIV-1 genotyping and phenotyping) which may lead to drug resistance.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0519
Date of REC Opinion
27 May 2015
REC opinion
Further Information Favourable Opinion