Expired Study
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Los Angeles, California 90025


Purpose:

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).


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


Study is Available At:


Original ID:

12-001792 (CTSI-PLACE)


NCT ID:

NCT02597790


Secondary ID:

N/A (Parent P30AI028697)


Study Acronym:

CTSI-PLACE


Brief Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kara W. Chew, M.D., M.S.
Principal Investigator
University of California, Los Angeles

Study Dates

Start Date:October 2013
Completion Date:January 2020
Completion Type:Anticipated
Primary Completion Date:January 2019
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 15, 2019
First Received Date:October 30, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reactive hyperemia index (RHI) by peripheral arterial tonometry (PAT)
Time Frame:Baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Soluble biomarkers (fasting lipid panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Time Frame:Baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reactive hyperemia index (RHI)
Time Frame:Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Soluble biomarkers (fasting lipid panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Time Frame:Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin resistance by HOMA-IR
Time Frame:Baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin resistance by HOMA-IR
Time Frame:Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Framingham risk score (FRS)
Time Frame:Baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Framingham risk score (FRS)
Time Frame:Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in RHI
Time Frame:Baseline to Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
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)
Time Frame:Baseline to Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in HOMA-IR
Time Frame:Baseline to Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in FRS
Time Frame:Baseline to Week 52
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Group B (HIV monoinfected)
Study Arm Type:Other
Arm Name:Group A (HIV/HCV coinfected)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck Sharp & Dohme Corp.

Samples and Retentions

Sample Retention:Samples With DNA
Description: Plasma and serum
Study Population: HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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