Status:
COMPLETED
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Lead Sponsor:
University of California, Davis
Conditions:
Human Immunodeficiency Virus Infection
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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 popula...
Detailed Description
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01869634
Start Date
June 1 2013
End Date
December 1 2016
Last Update
March 4 2020
Active Locations (1)
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1
University of California Davis
Sacramento, California, United States, 95617