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

HIV Clinical Trial

— CTSI-PLACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597790
• Other study ID #: 12-001792 (CTSI-PLACE)
• Secondary ID: N/A (Parent P30A
• Status: Completed
• Start date: October 2013
• Est. completion date: January 2020

Study information

• Verified date: December 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV

Locations

Country	Name	City	State
United States	UCLA CARE Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)	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)	Baseline
Secondary	Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	Serum hsCRP	Baseline
Secondary	Reactive Hyperemia Index (RHI)	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)	Week 52
Secondary	Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	Serum hsCRP	Week 52
Secondary	Insulin Resistance by HOMA-IR	fasting insulin (µU/mL) x fasting glucose (mg/dl) / 405	Baseline
Secondary	Insulin Resistance by HOMA-IR	fasting insulin (µU/mL) x fasting glucose (mg/dl) / 405	Week 52
Secondary	Framingham Risk Score (FRS), 10-year Risk (%)	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.	Baseline
Secondary	Framingham Risk Score (FRS), 10-year Risk (%)	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.	Week 52
Secondary	Change in RHI		Baseline to Week 52
Secondary	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)	Change in serum hsCRP level	Baseline to Week 52
Secondary	Change in HOMA-IR		Baseline to Week 52
Secondary	Change in Framingham Risk Score (10-year Risk, %)	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.	Baseline to Week 52