Hepatitis B and HIV Co-Infection in Patients in Uganda
Hepatitis B and HIV Co-Infection in Patients in Uganda
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.
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.
-  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