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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2020-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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HIV Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A (HIV/HCV coinfected)

No interventions assigned to this group

Group B (HIV monoinfected)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No