N/A
N=86
A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects
HIV · Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT02597790 ↗Enrolled (actual)
86
Serious AEs
—
Results posted
Jan 2022
Primary outcome: Primary: Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT) — 1.98; 2.15 ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT) |
1.98; 2.15 | — |
| SECONDARY Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163) |
1.05; 1.0 | — |
| SECONDARY Reactive Hyperemia Index (RHI) |
1.88; 2.09 | — |
| SECONDARY Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163) |
1.05; 1.0 | — |
| SECONDARY Insulin Resistance by HOMA-IR |
2.77; 2.13 | — |
| SECONDARY Insulin Resistance by HOMA-IR |
2.77; 2.13 | — |
| SECONDARY Framingham Risk Score (FRS), 10-year Risk (%) |
6.0; 5.0 | — |
| SECONDARY Framingham Risk Score (FRS), 10-year Risk (%) |
6.0; 5.0 | — |
| SECONDARY Change in RHI |
-0.16; -0.03 | — |
| 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) |
0.40; 0.00 | — |
| SECONDARY Change in HOMA-IR |
0.34; 0.28 | — |
| SECONDARY Change in Framingham Risk Score (10-year Risk, %) |
1.0; 0 | — |
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).
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02597790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.