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Hepatitis B and HIV Co-Infection in Patients in Uganda

NCT00782158 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6303

Last updated 2019-12-05

No results posted yet for this study

Summary

This study will determine the amount of liver scarring (fibrosis) or liver damage in people infected with 1) hepatitis B virus (HBV, a virus that can infect the liver); 2) HIV (the virus that causes AIDS); 3) both HBV and HIV; and 4) neither HBV nor HIV. Liver fibrosis and liver damage can have many causes, including alcohol, certain medicines, exposure to some contaminated foods and infections with viruses that affect the liver (such as HBV). About 25 million people in sub-Saharan Africa are infected with HIV and about 50 million with chronic HBV, yet very little information is available on how many people are infected with both viruses and the medical implications of co-infection.

Participants in Uganda s Rakai Health Sciences Program (RHSP) or Infectious Diseases Institute (IDI) clinic who are 18 years of age or older may be eligible for this study.

People enrolled in the study come to the clinic for at least one visit and may be asked to return yearly. During the visit, participants undergo the following procedures:

* Questionnaire and a short interview about their health and quality of life.
* Physical examination and blood draw. The blood is tested for HBV and other factors that may suggest liver disease. Blood drawn at previous clinic visits or from other studies may also be tested.
* Liver evaluation using a FibroScan, a medical device that uses elastic waves to measure liver stiffness in a process similar to ultrasound scanning. For this test, the subjects lies flat on the back with the arm extended out. The tip of the machine s probe is covered with gel and placed on the skin between the ribs at the level of the right lobe of the liver. The machine produces a little tap on the skin that sends a wave out and checks how fast the wave moves. The speed of the wave indicates the amount of scarring in the liver.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Steven J Reynolds, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

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

Timeline & Regulatory

Start
2008-10-27
Completion
2018-12-14

Countries

  • Uganda

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 NCT00782158 on ClinicalTrials.gov