Trial record 16 of 50 for:    " September 02, 2009":" October 02, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00987948
First received: September 29, 2009
Last updated: June 14, 2012
Last verified: June 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 in peripheral blood monocyte HIV DNA (HIV DNA within CD14+ PBMCs) [ Time Frame: week 24 of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of intensification with maraviroc [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in HIV DNA overall in PBMCs and in CD14- cells [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in plasma HIV RNA and CD4 count [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in neuropsychological testing parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2010
Estimated Study Completion Date: March 2013
Estimated 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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT00987948     History of Changes
Other Study ID Numbers: H005
Study First Received: September 29, 2009
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014