Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

NCT ID: NCT00987948

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-08-31

Brief 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).

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maraviroc

Group Type: EXPERIMENTAL

maraviroc (Selzentry)

Intervention Type: DRUG

dosage varies with other medications being taken; will follow package insert guidelines

Interventions

maraviroc (Selzentry)

dosage varies with other medications being taken; will follow package insert guidelines

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia M Shikuma, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii at Manoa

Locations

Hawaii Center for AIDS

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

H005

Identifier Type: -

Identifier Source: org_study_id