Clinical trial NCT02597790: A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects
Official title: Clinical and Translational Science Institute Prospective Longitudinal Assessment of Coinfected Subjects With HIV/Hepatitis C for Endothelial Function Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Hepatitis C
Keywords: endothelial function
cardiovascular risk
HIV
Hepatitis C
metabolic disease
inflammation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-11-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV

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).


Eligibility criteria: 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

Primary outcomes:
measure: Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
timeFrame: Baseline
Secondary outcomes:
measure: Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
timeFrame: Baseline
measure: Reactive Hyperemia Index (RHI)
timeFrame: Week 52
measure: Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
timeFrame: Week 52
measure: Insulin Resistance by HOMA-IR
timeFrame: Baseline
measure: Insulin Resistance by HOMA-IR
timeFrame: Week 52
measure: Framingham Risk Score (FRS), 10-year Risk (%)
timeFrame: Baseline
measure: Framingham Risk Score (FRS), 10-year Risk (%)
timeFrame: Week 52
measure: Change in RHI
timeFrame: Baseline to Week 52
measure: 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)
timeFrame: Baseline to Week 52
measure: Change in HOMA-IR
timeFrame: Baseline to Week 52
measure: Change in Framingham Risk Score (10-year Risk, %)
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kara W. Chew, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: