MedTrace Logo

Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection

NCT01350648 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 569

Last updated 2024-10-01

No results posted yet for this study

Summary

Background:

\- Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness, including liver cancer, and even death. This study will follow people who have hepatitis B or hepatitis C. The purpose is to understand more about how these viruses affect the immune system over the long term (up to 10 years). The study will also compare how these viruses affect people who do and do not have HIV, the virus that causes AIDS.

Objectives:

* To do a long-term study of hepatitis B and hepatitis C infection.
* To study the effects of hepatitis B and hepatitis C infection in people do and do not have HIV.

Eligibility:

\- People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care.

Design:

* Participants will be screened with a physical exam and medical history. Those who do not have a regular doctor to provide medical care during the study will not be able to take part.
* Participants will have yearly visits with study researchers for up to 10 years. These tests will be done at each visit.
* Medical history and physical exam.
* Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and quality of life.
* Blood and urine tests, including HIV testing.
* Tissue sample collections for those who have had a liver or other tissue biopsy.
* Participants may leave the study at any time. They will receive the standard of care from their regular doctor throughout the study.

Conditions

Sponsors & Collaborators

  • Washington D.C. Veterans Affairs Medical Center

    collaborator FED

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Colleen M Hadigan, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-23
Primary Completion
2022-03-04
Completion
2022-03-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350648 on ClinicalTrials.gov