Hepatitis B and HIV Co-Infection in Patients in Uganda
Condition: Hepatitis B; HIV Infections
MeSH terms: Infections; Communicable Diseases; Hepatitis A; HIV Infections; Hepatitis B; Coinfection; Hepatitis
Study type: Observational

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.
    

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.
    

Time perspective: Other
Keywords: HIV; Hepatitis B; Coinfection; Liver Fibrosis; Transient Elastography