Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Human Immunodeficiency Virus Infection
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus Infection focused on measuring HIV, cardiovascular risk, systemic immune activation
Eligibility 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.
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
HIV positive naive to ART
normal control volunteers
HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.
HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.