Status:
COMPLETED
Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
Pfizer
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 medicat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00987948
Start Date
January 1 2010
End Date
August 1 2013
Last Update
March 22 2017
Active Locations (1)
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1
Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816