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

Completed · Phase 4

Conditions studied: Human Immunodeficiency Virus Infection

In brief

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.

Key facts

Study ID

NCT01869634

Run by

University of California, Davis

People needed

37

Starts

2013-06-01

Expected to finish

2016-12-01

Last updated by the study team

2020-03-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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