Safety and Immune Response of BMS-936559 in HIV-Infected People Taking Combination Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      People infected with HIV may have low levels of the virus in their body, even if they are
      taking HIV medications. This study will evaluate the safety, pharmacokinetics (PK) (which is
      how the body interacts with drugs), and immune response to BMS-936559, a drug that will be
      administered by an intravenous (IV) infusion, in HIV-infected people receiving combination
      antiretroviral therapy (cART) who have viral load levels below the limit of detection.
    

Detailed description: 
      People infected with HIV who are taking cART and have low viral load levels may still have
      reservoirs of HIV remaining in their body. BMS-936559 is a drug that has been studied in
      previous clinical trials to treat various types of cancer. The purpose of this study is to
      evaluate the safety, PK, and immunotherapeutic activity of a single dose of BMS-936559
      (administered by an IV infusion) in HIV-infected people who are receiving cART and who have
      viral loads below the limit of detection. Researchers will also evaluate whether BMS-936559
      can reduce hidden reservoirs of HIV.

      Participants will be enrolled in four cohorts. Within each cohort, participants will be
      randomly assigned to receive BMS-936559 (Cohort 1: 0.3 mg/kg; Cohort 2: 1 mg/kg; Cohort 3: 3
      mg/kg; or Cohort 4: 10 mg/kg) or placebo. The four cohorts will be enrolled sequentially,
      with researchers reviewing safety data of the cohort before enrolling participants in the
      next cohort.

      Prior to study entry, all participants must have an eye exam and an electrocardiogram (ECG).
      At study entry, participants will undergo a medical and medication history review, physical
      examination, an eye exam, and a blood collection. Some female participants will have a
      pregnancy test. All participants will then receive a single IV infusion of their assigned
      dose of BMS-936559 or placebo. The infusion will occur over a period of 60 minutes, and
      participants will remain in the clinic for observation for an additional 12 hours. Additional
      study visits will occur at Days 3, 7, 14, 28, and Weeks 10, 16, 24, 36, and 48. These study
      visits may include a physical examination, blood collection, adherence assessments, and PK
      evaluations. Some participants may have additional eye exams during the study, on an
      as-needed basis.
    

Intervention name(s): BMS-936559; Placebo for BMS-936559
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg of BMS-936559, depending on which cohort participants are enrolled in, administered as an intravenous (IV) infusion; Sodium chloride for injection 0.9%, USP, administered as an IV infusion
Intervention MeSH terms: BMS-936559; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment