Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

Completed · Not applicable

Conditions studied: HIV Infections, AIDS

In brief

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 numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV medications.

Key facts

Study ID

NCT00661960

Run by

University of California, Davis

People needed

25

Starts

2008-03-01

Expected to finish

2011-07-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CARES Clinic — Sacramento, California, United States
• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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