Human Immunodeficiency Virus Infection Clinical Trial
Official title:
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Verified date | February 2020 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Systemic Immune Activation | Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6). | Baseline, 12 months | |
Primary | Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV | CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. | Baseline, 12 months | |
Secondary | Change in Percentage of Total Artery Diameter | computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy | Baseline, 12 months |
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