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

Completed

• Conditions: Hepatitis C; HIV

• Registration Number: NCT02597790
• Lead Sponsor: University of California, Los Angeles

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Primary Completion: 2019-01
• Study Completion: 2020-01
• Results First Submitted: 2021-01-30
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Results First Posted: 2022-01-20
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)	Baseline	Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)

Secondary Outcome Measures

Name	Time	Method
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	Week 52	Serum hsCRP
Change in HOMA-IR	Baseline to Week 52
Reactive Hyperemia Index (RHI)	Week 52	Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Insulin Resistance by HOMA-IR	Week 52	fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Change in Framingham Risk Score (10-year Risk, %)	Baseline to Week 52	Change in estimated 10-year risk (% risk) for developing coronary heart disease (CHD). Positive value indicates increase in estimated 10-year risk for CHD from baseline to Week 52. Negative value indicates decrease in estimated 10-year risk for CHD from baseline to Week 52.
Framingham Risk Score (FRS), 10-year Risk (%)	Week 52	Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is \<1 to \>/= 30% Higher risk % is worse predicted outcome.
Change in RHI	Baseline to Week 52
Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	Baseline to Week 52	Change in serum hsCRP level

Trial Locations

Locations (1)

UCLA CARE Center; 🇺🇸 Los Angeles, California, United States