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Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT01869634•University of California, Davis

View on ClinicalTrials.gov

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.

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 prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

University of California Davis

Sacramento, California, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

March 4, 2020

Enrollment

ACTUAL participants

Conditions

Human Immunodeficiency Virus Infection

Interventions

darunavir with ritonavir and fixed-dose viread+emtricitabine daily

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV

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