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Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00987948
First received: September 29, 2009
Last updated: February 1, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
HIV Infections Drug: maraviroc (Selzentry) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells [ Time Frame: Baseline to 24 weeks ]
    Week 24 minus baseline


Secondary Outcome Measures:
  • Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores [ Time Frame: Baseline to 24 Weeks ]
    The Z-score represents the number of standard deviations away from the mean, with positive Z-scores representing better neuropsychological performance and negative Z-scores representing poorer neuropsychological performance. Z-scores have been adjusted based on age- and education-matched norms.


Enrollment: 15
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc Drug: maraviroc (Selzentry)
dosage varies with other medications being taken; will follow package insert guidelines

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987948

Locations
United States, Hawaii
Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816
Sponsors and Collaborators
University of Hawaii
Pfizer
Investigators
Principal Investigator: Cecilia M Shikuma, M.D. University of Hawaii at Manoa
  More Information

Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT00987948     History of Changes
Other Study ID Numbers: H005
Study First Received: September 29, 2009
Results First Received: January 20, 2015
Last Updated: February 1, 2017

Keywords provided by University of Hawaii:
HIV
dementia
High HIV DNA within CD14+ PBMCs
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 19, 2017