View Clinical Trial (Medical Research Study)
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
| City: |
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Honolulu |
| State: |
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Hawaii |
| Zip Code: |
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96816 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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).
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT00987948 |
| Primary Contact: |
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Principal Investigator
Cecilia M Shikuma, M.D.
University of Hawaii at Manoa
Debra Ogata-Arakaki, RN
Phone: 737-2751
Email: ogataara@hawaii.edu
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| Backup Contact: |
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Email: lornan@hawaii.edu
Lorna Nagamine, RN
Phone: 737-2751
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| Location Contact: |
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Honolulu, Hawaii 96816
United States
Nancy Hanks, R.N.
Phone: 808-737-2751
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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