Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

ViiV Healthcare

Status and phase: Terminated; Phase 2

Conditions: HIV Infections

Treatments: Drug: Tenofovir (TDF); Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: BMS-955176; Drug: Dolutegravir (DTG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386098

AI468-048 (Other Identifier)

205892

Details and patient eligibility

About

The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and non-pregnant women, at least 18 years of age
• Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)
• CD4+ T-cell count > 50 cells/mm3
• Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC < 2.2; DTG; TDF)

Exclusion criteria

• Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens
• Resistance or partial resistance to any study drug determined by tests at Screening
• Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs
• 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: None (Open label)

---

86 participants in 5 patient groups

Arm 1: BMS-955176 + ATV + RTV + DTG

Experimental group

Description:

BMS-955176 at 120 mg tablet per day + Atazanavir boosted with ritonavir (ATV/r) 300/100 mg tablets per day + DTG 50 mg tablet per day, orally

Treatment:

Drug: Dolutegravir (DTG)

Drug: Ritonavir (RTV)

Drug: Atazanavir (ATV)

Drug: BMS-955176

Arm 2: TDF + ATV + RTV + DTG

Other group

Description:

TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally

Treatment:

Drug: Dolutegravir (DTG)

Drug: Tenofovir (TDF)

Drug: Ritonavir (RTV)

Drug: Atazanavir (ATV)

Arm 3: BMS-955176 + ATV + DTG

Experimental group

Description:

BMS-955176 at 120 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally

Treatment:

Drug: Dolutegravir (DTG)

Drug: Atazanavir (ATV)

Drug: BMS-955176

Arm 4: BMS-955176 + ATV + DTG

Experimental group

Description:

BMS-955176 at 180 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally

Treatment:

Drug: Dolutegravir (DTG)

Drug: Atazanavir (ATV)

Drug: BMS-955176

Arm 5: TDF + ATV + RTV + DTG

Other group

Description:

TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally

Treatment:

Drug: Dolutegravir (DTG)

Drug: Tenofovir (TDF)

Drug: Ritonavir (RTV)

Drug: Atazanavir (ATV)