Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

ViiV Healthcare

Status and phase: Active, not recruiting; Phase 3

Conditions: HIV Infections

Treatments: Drug: BMS-663068; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362503

2014-002111-41 (EudraCT Number)

AI438-047 (Other Identifier)

205888

Details and patient eligibility

About

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.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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371 participants in 3 patient groups

A1: BMS-663068

Experimental group

Description:

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.

Treatment:

Drug: BMS-663068

B1: Placebo + BMS-663068

Active Comparator group

Description:

Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Treatment:

Other: Placebo

Drug: BMS-663068

BMS-663068

Experimental group

Description:

BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Treatment:

Drug: BMS-663068