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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Efavirenz; Raltegravir Potassium; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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