Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:
Kara W. Chew (ucla)

Description

Summary

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 and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).

Official Title

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

Keywords

HIV Hepatitis C endothelial function cardiovascular risk metabolic disease inflammation Hepatitis Hepatitis A

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Location

  • UCLA CARE Center accepting new patients
    Los Angeles California 90025 United States

Lead Scientist

  • Kara W. Chew (ucla)
    Health Sciences Assistant Clinical Professor, Medicine. Authored (or co-authored) 15 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT02597790
Study Type
Observational
Last Updated