Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hawaii
• Collaborator: Pfizer
• Treatments: Maraviroc

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.