Clinical Trial Details

NCT ID: NCT02597790
Date Last Changed: May 10, 2016

Overview

Research Study Summary

A clinical study for patients with HIV or Hepatitis C

Research Study Title

Clinical and Translational Science Institute Prospective Longitudinal Assessment of Coinfected Subjects With HIV/Hepatitis C for Endothelial Function Study

Purpose

The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).

To Learn more

Recruitment Details

Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
University of California, Los Angeles
Duration
48 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria

  1. Men and women ≥ 18 years

  2. Hepatitis C negative or chronic hepatitis C infection

  3. Chronic HIV infection

  4. CD4+ T-cell count > 200 cells/mm3

  5. Plasma HIV-1 RNA < 50 copies/mL

  6. On continuous and stable ART for at least 12 weeks

  7. Ability and willingness to provide written informed consent.

Exclusion Criteria

  1. Known cardiovascular disease

  2. Diabetes requiring insulin therapy or hemoglobin A1c > 8%

  3. Inability to conform to requirements for PAT testing

  4. Decompensated liver disease

  5. Other known causes of significant liver disease

  6. Serious illness including acute liver-related disease and malignancy requiring systemic treatment or hospitalization within 12 weeks prior to study entry

  7. Presence of active or acute AIDS-defining opportunistic infections (OIs) within 12 weeks prior to study entry

  8. History of major organ transplantation with an existing functional graft and on immunosuppressive therapy

  9. History of known vascular or autoimmune disease

  10. Pregnancy

  11. HCV treatment (any approved or investigational agents) within 24 weeks prior to study entry

  12. Use of immune-based therapies or systemic corticosteroids within 12 weeks prior to study entry

  13. Advanced renal insufficiency as defined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or treatment by dialysis

Site Locations (1)

Country State City Zip Facility and Contact
United States California Los Angeles 90025 UCLA CARE Center
Jamie Murkey
310-562-6497
jmurkey@mednet.ucla.edu

Contact

Kara W. Chew, M.D., M.S.
310-825-6689
E-mail:

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