maraviroc intensification and peripheral blood monocyte hiv dna levels

Conditions: HIV Infections

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.

Keywords: hiv dementia high hiv dna within cd14+ pbmcs treatment experienced