A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects



Status:Active, not recruiting
Conditions:HIV / AIDS, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:October 2013
End Date:January 2020

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).


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
We found this trial at
1
site
UCLA CARE Ctr
9911 W Pico Blvd # 980
Los Angeles, California 90095
Phone: 310-825-7907
?
mi
from
Los Angeles, CA
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