Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
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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).
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: maraviroc (Selzentry) |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
- Change in peripheral blood monocyte HIV DNA (HIV DNA within CD14+ PBMCs) [ Time Frame: week 24 of study ] [ Designated as safety issue: No ]
- 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: | 15 |
Study Start Date: | January 2010 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Maraviroc |
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: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, Hawaii | |
Hawaii Center for AIDS | |
Honolulu, Hawaii, United States, 96816 |
Principal Investigator: | Cecilia M Shikuma, M.D. | University of Hawaii at Manoa |
No publications provided
Responsible Party: | University of Hawaii |
ClinicalTrials.gov Identifier: | NCT00987948 History of Changes |
Other Study ID Numbers: | H005 |
Study First Received: | September 29, 2009 |
Last Updated: | June 14, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Hawaii:
HIV dementia High HIV DNA within CD14+ PBMCs treatment experienced |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 05, 2013