Hepatitis B and HIV Co-Infection in Patients in Uganda

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00782158
First received: October 29, 2008
Last updated: June 6, 2014
Last verified: April 2014
  Purpose

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.

Condition
Hepatitis B
HIV Infections

Study Type: Observational
Official Title: Hepatitis B and HIV Co-Infection in Uganda

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Liver fibrosis and hepatoxicity

Estimated Enrollment: 11000
Study Start Date: October 2008
Detailed Description:

While there are around 25 million HIV-infected persons in sub-Saharan Africa, there are also an estimated 50 million with chronic hepatitis B virus (HBV) infection. Yet data from Africa on the prevalence and clinical implications of HIV/HBV co-infection are sparse or unavailable. The scale-up of' HIV treatment with antiretroviral medication (ARVs) in Africa, should result in substantial reductions in morbidity and mortality. In developed countries, however, improved survival with highly active antiretroviral therapy (HAART) has been associated with notable increases in mortality due to liver disease among HIV-infected persons. Also, persons co-infected with hepatitis viruses have significantly higher liver-related toxicity with ARVs compared to persons infected with HIV alone. Our protocol will investigate predictors of liver disease among co-infected participants. The proposed study directly addresses the problem of HIV/HBV co-infection by examining the association of HBV viral markers with the development of significant liver fibrosis (defined by transient elastography). In addition to strengthening the clinical research capacity of our Ugandan colleagues, completion of our study aims will provide needed information for understanding the complex interaction of HBV and HIV, for projecting the future burden of liver disease related to the HIV epidemic, for clinical management of HBV infection in the setting of co-infection with HIV, and for optimizing the benefits while mitigating the potential deleterious consequences of antiretroviral programs in Africa.

Serological screening will be performed on up to 11,000 subjects in order to identify up to 2,400 subjects to be recruited into the clinical protocol. All people who choose to participate in the study will be asked to come to the clinic for at least 1 visit. If continuing funding is obtained, participants may be asked to return for additional yearly follow-up visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Willing and able to provide individual informed consent
    2. Currently being followed at the RHSP or IDI Adult Infectious Disease Clinic
    3. Persons aged 18 years and older

EXCLUSION CRITERIA:

  1. Age less than 18 years
  2. Women who are pregnant
  3. Participants with a cardiac device (i.e., pacemaker)
  4. Participants not willing to allow storage of samples
  5. Participants not able to follow study instructions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782158

Locations
Uganda
Infectious Diseases Institute
Kampala, Uganda
International Ctr for Excellence in Research and Rakai Health Sciences Program
Rakai, Uganda
Sponsors and Collaborators
Investigators
Principal Investigator: Steven J Reynolds, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00782158     History of Changes
Other Study ID Numbers: 999909016, 09-I-N016
Study First Received: October 29, 2008
Last Updated: June 6, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HIV
Hepatitis B
Coinfection
Liver Fibrosis
Transient Elastography

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Coinfection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis B
HIV Infections
Infection
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Parasitic Diseases
Picornaviridae Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014