None listed
Conditions
Interventions
Subjects in each arm and per stage will begin QD dosing (in the morning, with a meal) with
BMS-955176 in combination with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG),
Arm 1: BMS-955176 120 mg QD + ATV/r 300/100 mg QD + DTG 50 mg QD, OR

Arm 2: TDF 300 mg QD + ATV/r 300/100 mg QD + DTG 50 mg QD
Stage 2:

Arm 3: BMS-955176 120 mg QD + ATV 400 mg QD + DTG 50 mg QD, OR

Arm 4: BMS-955176 180 mg QD + ATV 400 mg QD + DTG 50 mg QD, OR

Arm 5: TDF 300 mg QD + ATV/r 300/100 mg QD + DTG 50 mg QD
Sponsors
ViiV Healthcare UK Limited,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Men and non-pregnant women, at least 18 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)  Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of ARV (with or without documented resistance)  Confirmed Plasma HIV-1 RNA  400 copies/mL  CD4+ T-cell count > 50 cells/mm3  Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC < 2.2; DTG; TDF)
Exclusion criteria
Exclusion criteria:  Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens  Resistance or partial resistance to any study drug  Three or more of the following PI mutations, historical or documented: M36I/V, M46I/L/T, G48M/V, I54V/L/T/M/A, G73S/A/C/T, V82A/F/T/S/I, or L90M  Any major ATV mutations, historical or documented: I50L, I84V/A, N88D/S  Any major TDF mutation, historical or documented: K65R or T69ins  Three or more of the following non-accessory thymidine analogue mutations (TAMs): M41L, D67N, K70R, L210W, T215Y/F, K219Q/E  Any major mutations for raltegravir (RAL), elvitegravir (or clinically suspected INI resistance), historical or documented: T66IAK, E92Q, S147G, N155H, Q148H/K/R, Y143C/H/R, E157Q  Chronic HBV/HCV (Positive blood screen for HBsAg; Positive blood screen for HCV Ab and HCV RNA)  ALT or AST > 3 × ULN  Alkaline Phosphatase > 5 × ULN  Bilirubin  1.5 × ULN  History of decompensated cirrhosis or active decompensated cirrhosis  Hemoglobin < 8.0 g/dL  Platelets < 50,000 cells/mm3
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Puerto Rico, Russian Federation, South Africa, Taiwan, Thailand
Contacts
Public ContactStela Lopez
PPD Peru S.A.C.
Outcome results
None listed