Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

NCT00987948

Last updated date
Study Location
Hawaii Center for AIDS
Honolulu, Hawaii, 96816, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: maraviroc (Selzentry)
dosage varies with other medications being taken; will follow package insert guidelines
Study Arms  ICMJE Experimental: Maraviroc
Intervention: Drug: maraviroc (Selzentry)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00987948
Other Study ID Numbers  ICMJE H005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Hawaii
Study Sponsor  ICMJE University of Hawaii
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Cecilia M Shikuma, M.D.University of Hawaii at Manoa
PRS Account University of Hawaii
Verification Date February 2017

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