Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: David Asmuth, MD; University of California, Davis
• Treatments: Darunavir; Emtricitabine; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Willing to sign consent form

• Naïve to ART (remote ART use >5 years will be considered on a case by case basis)

• No known GI or cardiovascular disease

• Between the ages of 18 and 60

• No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.

• All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.

• Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease

• There are no CD4+ T-cell count or HIV plasma viral load restrictions.

Exclusion Criteria:

• Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))

• Thrombocytopenia (platelet count <50.000 within 6 weeks)

• Contra-indications to upper endoscopy or conscious sedation

• Anemia (>grade 1 [appendix 1])

• Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.

• Renal insufficiency (serum Creatinine >1.2 ULN)

• History of chronic proteinuria that could impact viread use.

• Allergy to contrast used for CT angiography

• Requirement to take medications that are contraindicated with study ART regimen.