NCT01448915

Brief Summary

The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. Research procedures will focus on determining liver disease prevalence and severity within this population. This is an observational study without study specific interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
828

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

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

First Submitted

Initial submission to the registry

September 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
9.5 years until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

September 27, 2011

Last Update Submit

February 17, 2022

Conditions

HIV InfectionHepatitis C

Keywords

HIVHuman immunodeficiency virusAcquired Immune Deficiency Syndrome VirusAIDS virusImmunodeficiency Virus, HumanVirus, Human ImmunodeficiencyHepatitis CHepatitis C, chronicHepatitis C virusHepatitis C antibodiesHepatitis C antigens

Outcome Measures

Primary Outcomes (1)

  • Hepatitis C Treatment Uptake and HCV cure

    The proportion of persons with HIV and HCV coinfection who achieve HCV cure

    5 years

Secondary Outcomes (2)

  • Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure

    5 years

  • Liver stiffness measurement by elastography in persons with HIV infection

    5 years

Study Arms (1)

Persons with HIV and HCV coinfection

Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective observational cohort of HIV-infected persons receiving medical care at the Johns Hopkins Hospital. Participants are eligible if they are HCV antibody positive and use or have used drugs.

You may qualify if:

  • Current or prior drug use
  • Reactive HCV antibody
  • Reactive HIV antibody

You may not qualify if:

  • Women may not undergo FibroScan while pregnant
  • Persons with implanted cardiac devices may not undergo FibroScan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

  • Bilal U, Lau B, Lazo M, McCaul ME, Hutton HE, Sulkowski MS, Moore RD, Chander G. Interaction Between Alcohol Consumption Patterns, Antiretroviral Therapy Type, and Liver Fibrosis in Persons Living with HIV. AIDS Patient Care STDS. 2016 May;30(5):200-7. doi: 10.1089/apc.2016.0010.

    PMID: 27158847BACKGROUND

  • Falade-Nwulia O, Sutcliffe C, Moon J, Chander G, Wansom T, Keruly J, Katzianer J, Nathanson A, Marks J, Mehta S, Thomas D, Moore R, Sulkowski M. High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center. Hepatology. 2017 Nov;66(5):1402-1412. doi: 10.1002/hep.29308. Epub 2017 Oct 11.

    PMID: 28608973RESULT

  • Wansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.

    PMID: 28480293RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma specimens are collected at regular intervals

MeSH Terms

Conditions

HIV InfectionsHepatitis CAcquired Immunodeficiency SyndromeHepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesSlow Virus DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark S. Sulkowski, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 7, 2011

Study Start

March 31, 2021

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

February 21, 2022

Record last verified: 2021-02

Locations

US(1)