Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

ViiV Healthcare

Status and phase: Terminated; Phase 2

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: EFV; Drug: TDF/FTC; Drug: BMS-955176

Study type: Interventional

Funder types: Industry

Identifiers

NCT02415595

AI468-038 (Other Identifier)

205891

2013-005487-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Men and non-pregnant women, at least 18 years of age
• Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug
• Plasma HIV-1 RNA ≥ 1000 copies/mL
• CD4 T-cell count > 200 cells/mm3

Exclusion Criteria:

• Resistance or partial resistance to any study drug determined by tests at Screening
• Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors
• Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
• Blood tests that indicate normal liver function
• Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

210 participants in 4 patient groups

Arm 1: BMS-955176 60 mg + TDF/FTC

Experimental group

Description:

BMS-955176 at 60 mg active dose per day + BMS-955176 placebo matching 120 mg + efavirenz (EFV) placebo matching 600 mg + tenofovir/emtricitabine (TDF/FTC) 300/200 mg per day, orally

Treatment:

Drug: TDF/FTC

Drug: BMS-955176

Arm 2: BMS-955176 120 mg + TDF/FTC

Experimental group

Description:

BMS-955176 placebo matching 60 mg + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC 300/200mg per day, orally

Treatment:

Drug: TDF/FTC

Drug: BMS-955176

Arm 3: BMS-955176 180 mg + TDF/FTC

Experimental group

Description:

BMS-955176 at 60mg active dose per day + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC at 300/200mg per day, orally

Treatment:

Drug: TDF/FTC

Drug: BMS-955176

Arm 4: EFV + TDF/FTC

Active Comparator group

Description:

BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day

Treatment:

Drug: TDF/FTC

Drug: EFV