|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Hawaii |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | University of Hawaii |
| ClinicalTrials.gov Identifier: | NCT00987948 |
Purpose
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Maraviroc: Experimental |
Drug: maraviroc (Selzentry)
dosage varies with other medications being taken; will follow package insert guidelines
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory parameters documented within 30 days prior to study entry:
Exclusion Criteria:
Contacts and Locations| Contact: Debra Ogata-Arakaki, RN | 737-2751 | ogataara@hawaii.edu |
| Contact: Lorna Nagamine, RN | 737-2751 | lornan@hawaii.edu |
| United States, Hawaii | |
| Hawaii Center for AIDS | |
| Honolulu, Hawaii, United States, 96816 | |
| Principal Investigator: | Cecilia M Shikuma, M.D. | University of Hawaii at Manoa |
More Information
| Responsible Party: | University of Hawaii at Manoa ( Cecilia M. Shikuma M.D., Professor of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa ) |
| Study ID Numbers: | H005 |
| Study First Received: | September 29, 2009 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00987948 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
HIV dementia High HIV DNA within CD14+ PBMCs treatment experienced |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |