Phase 4
N=37
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Human Immunodeficiency Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01869634 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: 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 — 80; 478; 213 cells / mm^2 — p=0.0025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- darunavir with ritonavir and fixed-dose viread+emtricitabine daily (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
80; 478; 213 | 0.0025 sig |
| SECONDARY Change in Percentage of Total Artery Diameter |
57; 53 | 0.032 sig |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01869634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.