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Completed

NCT Number: NCT02597790

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

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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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Inflammation Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA CARE Center

Los Angeles, California, 90025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ≥ 18 years
  • Hepatitis C negative or chronic hepatitis C infection
  • Chronic HIV infection
  • CD4+ T-cell count > 200 cells/mm3
  • Plasma HIV-1 RNA < 50 copies/mL
  • On continuous and stable ART for at least 12 weeks
  • Ability and willingness to provide written informed consent.

Exclusion criteria

  • Known cardiovascular disease
  • Diabetes requiring insulin therapy or hemoglobin A1c > 8%
  • Inability to conform to requirements for PAT testing
  • Decompensated liver disease
  • Other known causes of significant liver disease
  • Serious illness including acute liver-related disease and malignancy requiring systemic treatment or hospitalization within 12 weeks prior to study entry
  • Presence of active or acute AIDS-defining opportunistic infections (OIs) within 12 weeks prior to study entry
  • History of major organ transplantation with an existing functional graft and on immunosuppressive therapy
  • History of known vascular or autoimmune disease
  • Pregnancy
  • HCV treatment (any approved or investigational agents) within 24 weeks prior to study entry
  • Use of immune-based therapies or systemic corticosteroids within 12 weeks prior to study entry
  • Advanced renal insufficiency as defined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or treatment by dialysis

Treatment and study plan

Primary outcomes

  1. Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)

    Time frame: 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 outcomes

  1. Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)

    Time frame: Baseline

    Serum hsCRP

  2. Reactive Hyperemia Index (RHI)

    Time frame: 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)

  3. Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)

    Time frame: Week 52

    Serum hsCRP

  4. Insulin Resistance by HOMA-IR

    Time frame: Baseline

    fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405

  5. Insulin Resistance by HOMA-IR

    Time frame: Week 52

    fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405

  6. Framingham Risk Score (FRS), 10-year Risk (%)

    Time frame: Baseline

    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.

  7. Framingham Risk Score (FRS), 10-year Risk (%)

    Time frame: 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.

  8. Change in RHI

    Time frame: Baseline to Week 52

  9. 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)

    Time frame: Baseline to Week 52

    Change in serum hsCRP level

  10. Change in HOMA-IR

    Time frame: Baseline to Week 52

  11. Change in Framingham Risk Score (10-year Risk, %)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: CTSI-PLACE

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Nov 5, 2015
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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