Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: BMS-955176; Placebo matching with BMS-955176; Atazanavir; Ritonavir; Tenofovir; Emtricitabine
Intervention description: BMS-955176; Placebo matching with BMS-955176; Atazanavir; Ritonavir; Tenofovir; Emtricitabine
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; BMS-955176
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to study the safety and tolerability of a HIV drug and
      to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected
      patients
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Age 18-55 years inclusive

          -  Men and women: (Parts A and C); men only (Part B)

          -  Women of childbearing potential (WOCBP) must not be pregnant and nursing

          -  BMI: 18.0-35.0 kg/m2

          -  Subjects are infected with HIV-1 (clades B or C) and meet following criteria at the
             screening:

             i) Plasma HIV-1 RNA ≥5,000 copies/mL; ii) Antiretroviral treatment naive (defined as
             <1 week of ARV treatment) or ART-experienced (protease inhibitor and/or maturation
             inhibitor naive); iii) Subjects are not eligible for HIV-1 treatment based on the
             United States Department of Health and Human Services Panel on Antiretroviral
             Guidelines for Adults and Adolescents or have declined initiation of cART iv) CD4+
             lymphocyte measurement ≥200 cells/μL; v) In Parts A and B, all subjects are infected
             with HIV-1 clade B vi) In Part C, all subjects are infected with HIV-1 clade C

        Exclusion Criteria:

          -  History of genotypic and/or phenotypic drug resistance testing showing resistance to
             protease inhibitors

          -  Any significant acute or chronic medical illness which is not stable or is not
             controlled with medication or not consistent with HIV-1 infection

          -  Receive antiretroviral treatment within 12 weeks prior to screening

          -  Currently co-infected with hepatitis C or hepatitis B

          -  Previously received an HIV maturation inhibitor or HIV protease inhibitor

          -  Current or recent (within 3 months of study drug administration) gastrointestinal
             disease

          -  Any major surgery within 4 weeks of study drug administration

          -  Acute diarrhea lasting ≥1 day, within 3 weeks prior to randomization

          -  Subjects with history of Gilbert's syndrome

          -  Subjects previously received an HIV maturation inhibitor or HIV protease inhibitor

          -  A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic
             arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes. A
             personal or family history of long QT syndrome

          -  Patients who are unwilling to practice adequate infection protection during and after
             study participation to minimize potential for spread of HIV infection, including HIV
             which may have developed resistance to HIV maturation inhibitor and/or ATV

          -  Any gastrointestinal surgery that could impact upon the absorption of study drug

          -  Smoking >10 cigarettes per day

          -  PR ≥210 msec; QRS ≥120 msec; QT ≥500 msec; and QTcF ≥470 msec for women and ≥450 msec
             for men

          -  Evidence of second or third degree heart block prior to study drug

          -  Absolute Neutrophil Count <(ANC) 0.7 x lower limit of normal (LLN)

          -  Hemoglobin <0.8 x LLN

          -  Alanine aminotransferase (ALT) >1.25 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) >1.25 x ULN

          -  Total Bilirubin >1.25 x ULN

          -  Creatinine clearance <60 mL/mim

          -  Positive urine screen for drugs of abuse without a valid prescription (subjects
             positive for cannabinoids and/or amphetamines will be included)

          -  Positive blood screen for hepatitis C virus (HCV) RNA, hepatitis B surface antigen
             (consistent with active or chronic hepatitis B), or HIV-2 antibody

          -  History of any significant drug allergy