Status:
COMPLETED
Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
Lead Sponsor:
University of California, Davis
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the number...
Detailed Description
While the world-wide AIDS epidemic continues to impact millions of individuals, effective anti-HIV medications have substantially reduced morbidity and mortality for those patients able to adhere to c...
Eligibility Criteria
Inclusion
- willing to sign consent form
- no known GI pathology
- no anticipated antiretroviral therapy adjustments or changes
- males \& females between the ages of 18 \& 50 years
- no active opportunistic infections (OI) or therapy for OI within 30 days of entry
- can be on secondary prophylaxis with a history of AIDS defining illness
- per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study
Exclusion
- abnormal coagulation parameters (PT \> or equal to 1.2 ULN)
- thrombocytopenia (platelet count \< 50,000 within 6 weeks)
- contra-indications to upper endoscopy or conscious sedation
- anemia (\> or equal to grade 1)
- aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00661960
Start Date
March 1 2008
End Date
July 1 2011
Last Update
May 30 2017
Active Locations (2)
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1
CARES Clinic
Sacramento, California, United States, 95814
2
UC Davis Medical Center
Sacramento, California, United States, 95817