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
Information provided by (Responsible Party):
University of Hawaii
First received: September 29, 2009
Last updated: June 14, 2012
Last verified: June 2012
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).
Drug: maraviroc (Selzentry)
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
Drug: maraviroc (Selzentry)
dosage varies with other medications being taken; will follow package insert guidelines
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00987948
|Hawaii Center for AIDS
|Honolulu, Hawaii, United States, 96816 |
University of Hawaii
||Cecilia M Shikuma, M.D.
||University of Hawaii at Manoa
No publications provided
||University of Hawaii
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 29, 2009
||June 14, 2012
||United States: Institutional Review Board
Keywords provided by University of Hawaii:
ClinicalTrials.gov processed this record on April 23, 2015
High HIV DNA within CD14+ PBMCs