HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

ViiV Healthcare

Status and phase: Completed; Phase 2

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-663068 400 mg; Drug: Atazanavir 300 mg; Drug: Tenofovir 300 mg; Drug: BMS-663068 800 mg; Drug: Ritonavir 100 mg; Drug: BMS-663068 1200 mg; Drug: BMS-663068 600 mg; Drug: Raltegravir 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01384734

205889

AI438-011 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Full description

Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.

Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)

Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
• Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
• Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1 μM
• Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

Exclusion criteria

• History (or evidence at Screening) of genotypic resistance to any component of the study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)]
• Certain laboratory and electrocardiogram (ECG) values

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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254 participants in 5 patient groups

Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir

Experimental group

Description:

Treatment Group 1

Treatment:

Drug: Raltegravir 400 mg

Drug: Tenofovir 300 mg

Drug: BMS-663068 400 mg

Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir

Experimental group

Description:

Treatment Group 2

Treatment:

Drug: Raltegravir 400 mg

Drug: Tenofovir 300 mg

Drug: BMS-663068 800 mg

Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir

Experimental group

Description:

Treatment Group 3

Treatment:

Drug: BMS-663068 600 mg

Drug: Raltegravir 400 mg

Drug: Tenofovir 300 mg

Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir

Experimental group

Description:

Treatment Group 4

Treatment:

Drug: Raltegravir 400 mg

Drug: Tenofovir 300 mg

Drug: BMS-663068 1200 mg

Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir

Active Comparator group

Description:

Treatment Group 1 (reference arm)

Treatment:

Drug: Raltegravir 400 mg

Drug: Atazanavir 300 mg

Drug: Tenofovir 300 mg

Drug: Ritonavir 100 mg