Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Hawaii.
Recruitment status was  Active, not recruiting
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

September 29, 2009
June 14, 2012
January 2010
November 2012   (final data collection date for primary outcome measure)
Change in peripheral blood monocyte HIV DNA (HIV DNA within CD14+ PBMCs) [ Time Frame: week 24 of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00987948 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety and tolerability of intensification with maraviroc [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in HIV DNA overall in PBMCs and i 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 ]
  • Change in hs-CRP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
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

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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: maraviroc (Selzentry)
dosage varies with other medications being taken; will follow package insert guidelines
Experimental: Maraviroc
Intervention: Drug: maraviroc (Selzentry)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
March 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00987948
H005
No
University of Hawaii
University of Hawaii
Pfizer
Principal Investigator: Cecilia M Shikuma, M.D. University of Hawaii at Manoa
University of Hawaii
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP