NCT01208376

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 20, 2016

Status Verified

May 1, 2016

Enrollment Period

7.8 years

First QC Date

September 22, 2010

Last Update Submit

December 19, 2016

Conditions

HIV Infection and Chronic Alanine Aminotransferase Elevation

Outcome Measures

Primary Outcomes (1)

  • Liverfibrosis

    3 years

Study Arms (2)

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

FibroscanOTHER

Fibroscan and Serum Fibrose-marker

Also known as: Fibroscan and Serum Fibrose-marker
always normal ALTunexplained chronic ALT elevation

Eligibility Criteria

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

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

December 20, 2016

Record last verified: 2016-05

Locations

CH(1)