Status:
COMPLETED
A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy
Lead Sponsor:
University of California, Davis
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This research study is being done to find out how the immune system in the small intestines improves after taking antiretroviral (anti-HIV) medications. Biopsies (small snips of tissue) will be taken ...
Detailed Description
Despite improved survival, durable virologic suppression, and increases in peripheral CD4+ T-cell counts in patients receiving potent antiretroviral therapy (ART), immune reconstitution remains incomp...
Eligibility Criteria
Inclusion
- Males and Females ages 18 years to 60 years inclusive
- HIV positive (no anticipated antiretroviral therapy adjustments/changes)
- CD4 count greater than or equal to 50 cells/ml within 30 days of screening
- CCR5 tropism by Trofile ES(TM)
- Can be on secondary prophylaxis with a history of AIDS defining illness
- All females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from sexual activity while on study.
- willing to sign consent form
- HIV Negative individuals will also be recruited for this study as a Control Group
Exclusion
- allergy to peanuts or soya (maraviroc contains soya lecithin)
- abnormal coagulation parameters (PT greater than or equal to 1.2 ULN)
- thrombocytopenia (platelet count less than 50,000 within 6 weeks)
- known GI pathology
- contra-indications to upper endoscopy or conscious sedation
- anemia greater than grade 1
- any active acute opportunistic infection (OI) or therapy for acute OI within 30 days of entry into study
- positive pregnancy test
- aspirin, ibuprofen, warfarin, or other agents that interfere with the coagulation cascade taken within 1 week of endoscopy
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00870363
Start Date
April 1 2009
End Date
April 1 2013
Last Update
May 30 2017
Active Locations (1)
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1
CARES Clinic
Sacramento, California, United States, 95811