Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: maraviroc (Selzentry)
Intervention description: dosage varies with other medications being taken; will follow package insert guidelines
Intervention MeSH terms: Maraviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; dementia; High HIV DNA within CD14+ PBMCs; treatment experienced

Summary:

      High levels of HIV infection within blood monocyte/macrophages (a type of white cells in the
      bloodstream) increases risk of dementia in HIV-infected individuals. Maraviroc (Selzentry) is
      a HIV medication that works by blocking the entry of HIV in cells including
      monocytes/macrophages that use a receptor called CCR5. The study hypothesis is that the
      addition of Maraviroc to a HIV antiretroviral regimen in HIV-infected individuals with high
      levels of HIV-infected monocyte/macrophages will lead to a decrease in the levels of infected
      monocyte/macrophages and to decrease in brain inflammation as studied by magnetic resonance
      spectroscopy (MRS, a form of MRI study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection as documented by ELISA and confirmed by either Western blot, HIV-1
             culture, HIV-1 antigen, plasma HIV-1 RNA by RT-PCR or bDNA at any time prior to study
             entry.

          -  Receipt of ARV medication uninterrupted for > 1 year leading up to the screening
             period with demonstrated HIV RNA < 50 copies/ml for a period of 1 year."

          -  Willingness for both males and females of childbearing potential to utilize 2
             effective contraception methods (2 separate forms, one of which must be an effective
             barrier method), be non-heterosexually active or have a an exclusive vasectomized
             partner from screening throughout the duration of the study treatment and for 30 days
             following the last dose of study drugs.

          -  Age >18 years.

          -  Ability and willingness to provide written informed consent

          -  The following laboratory parameters documented within 30 days prior to study entry:

               -  Hemoglobin >8.0

               -  Absolute neutrophil count >500

               -  Platelet count >40,000

               -  AST (SGOT) and ALT (SGPT) <5 x ULN

               -  Creatinine <1.5 x ULN

               -  Lipase <2.0 x ULN

               -  Estimated creatinine clearance > 60 mL/min.

          -  HIV DNA within peripheral blood mononuclear cells > 100 copies/mL

          -  Not currently receiving Maraviroc as part of ARV regimen

        Exclusion Criteria:

          -  Past or present HIV opportunistic infection of the brain, learning disability, head
             injury with prolonged loss of consciousness or cognitive sequelae, or other non-HIV
             risk factor that may impact cognitive performance.

          -  Any factor that precludes MRI scan including presence of metal or exposure to metal
             work (e.g., metal grinder/worker) and claustrophobia

          -  History of seizure disorder

          -  History of myocardial infarction, angina, congestive heart failure, peripheral
             vascular disease, angioplasty or cardiac surgery

          -  Current malignancy or history of past malignancies excluding basal cell CA

          -  Any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study
             entry.

          -  Any vaccination within 30 days of study entry.

          -  Requirement for acute therapy for other AIDS-defining illness or other serious medical
             illnesses (in the opinion of the site investigator) within 14 days prior to study
             entry.

          -  Other chronic illnesses including diabetes, autoimmune diseases, and endocrinopathies,
             except subjects on stable physiologic replacement therapy for low testosterone or
             thyroid levels

          -  Known hypersensitivity to Maraviroc

          -  Any condition which, in the opinion of the investigator, would compromise the
             subject's ability to participate in the study

          -  Current active substance or alcohol dependence

          -  Pregnancy or breast-feeding, intent to become pregnant during the course of the study.