Prevalence of Liver Fibrosis and Progression of Liver Fib... | NCT01208376

Studies
Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

NCT01208376

Sponsor

Helen Kovari-Kramer

Status

Unknown status

Last Update Posted

Dec 20, 2016Estimated

Enrollment

195Actual

Phase

Not provided

Conditions

HIV Infection and Chronic Alanine Aminotransferase Elevation

Interventions

Fibroscan

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Aug 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Sep 22, 2010

First Submission Date that Met QC Criteria

Sep 22, 2010

First Posted Date

Sep 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2016

Last Update Posted Date

Dec 20, 2016Estimated

Name	Class
Swiss HIV Cohort Study	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. In a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

195Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
unexplained chronic ALT elevation		Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation	Other: Fibroscan
always normal ALT		Control patients: HIV-infected, always normal ALT values	Other: Fibroscan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibroscan	Other	Fibroscan and Serum Fibrose-marker	always normal ALT unexplained chronic ALT elevation

Measure	Description	Time Frame
Liverfibrosis		3 years

Eligibility Module

Eligibility Criteria

Inclusion criteria: Case patients:

HIV-1 infection
no hepatitis B and C coinfection
chronic alanine aminotransferase (ALT) elevation after 1.1.2007
signed informed consent
no other common cause of liver disease

Control patients:

HIV-infection
no hepatitis B and C coinfection
no ALT elevation after 1.1.2002, the date when ALT values were regularly collected in the Swiss HIV Cohort Study (SHCS)
no known chronic liver disease

Exclusion criteria: please see inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided