NCT02597790

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2022

Completed
Last Updated

January 20, 2022

Status Verified

December 1, 2021

Enrollment Period

5.3 years

First QC Date

October 30, 2015

Results QC Date

January 30, 2021

Last Update Submit

December 20, 2021

Conditions

HIVHepatitis C

Keywords

endothelial functioncardiovascular riskHIVHepatitis Cmetabolic diseaseinflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

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

    Baseline

  • Reactive Hyperemia Index (RHI)

    Week 52

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

    Week 52

  • Insulin Resistance by HOMA-IR

    Baseline

  • Insulin Resistance by HOMA-IR

    Week 52

  • +6 more secondary outcomes

Study Arms (2)

Group A (HIV/HCV coinfected)

Group B (HIV monoinfected)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA CARE Center

Los Angeles, California, 90025, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum

MeSH Terms

Conditions

Hepatitis CMetabolic DiseasesInflammation

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kara Chew, MD, MS
Organization
David Geffen School of Medicine at UCLA
kchew@mednet.ucla.edu
310-825-0796

Study Officials

  • Kara W. Chew, M.D., M.S.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 5, 2015

Study Start

October 1, 2013

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

January 20, 2022

Results First Posted

January 20, 2022

Record last verified: 2021-12

Locations

US(1)