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Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
maraviroc (Selzentry)
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, dementia, High HIV DNA within CD14+ PBMCs, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hawaii Center for AIDS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maraviroc

Arm Description

Outcomes

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
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
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.

Full Information

First Posted
September 29, 2009
Last Updated
February 1, 2017
Sponsor
University of Hawaii
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00987948
Brief Title
Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, dementia, High HIV DNA within CD14+ PBMCs, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maraviroc
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
maraviroc (Selzentry)
Intervention Description
dosage varies with other medications being taken; will follow package insert guidelines
Primary Outcome Measure Information:
Title
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
Description
Week 24 minus baseline
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores
Description
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.
Time Frame
Baseline to 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia M Shikuma, M.D.
Organizational Affiliation
University of Hawaii at Manoa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawaii Center for AIDS
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States

12. IPD Sharing Statement

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