This trial is active, not recruiting.

Condition hiv infections
Treatment maraviroc (selzentry)
Phase phase 2
Sponsor University of Hawaii
Collaborator Pfizer
Start date January 2010
End date November 2012
Trial size 15 participants
Trial identifier NCT00987948, H005


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
maraviroc (selzentry)
dosage varies with other medications being taken; will follow package insert guidelines

Primary Outcomes

Change in peripheral blood monocyte HIV DNA (HIV DNA within CD14+ PBMCs)
time frame: week 24 of study

Secondary Outcomes

Safety and tolerability of intensification with maraviroc
time frame: 24 weeks
Change in HIV DNA overall in PBMCs and in CD14- cells
time frame: 24 weeks
Change in plasma HIV RNA and CD4 count
time frame: 24 weeks
Change in neuropsychological testing parameters
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Pilot Study of the Effect of Maraviroc Intensification on Peripheral Blood Monocyte HIV DNA Levels When Given to HIV-Infected Subjects Stable on Highly Active Antiretroviral Therapy With Undetectable Plasma HIV RNA
Principal investigator Cecilia M Shikuma, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by University of Hawaii.