Hepatitis B and HIV Co-Infection in Patients in Uganda

NCT00782158 | Completed

• 2 other identifiers: 99990901609-I-N016
• Study Type: observational
• Target: 6,303
• Locations: 1 country
• Sites: 2

Brief 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

Hepatitis B; HIV Infections

Keywords

HIV; Hepatitis B; Coinfection; Liver Fibrosis; Transient Elastography

Outcome Measures

Primary Outcomes (1)

• Liver fibrosis and hepatoxicity

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age less than 18 years
• Women who are pregnant
• Participants with a cardiac device (i.e., pacemaker)
• Participants not willing to allow storage of samples
• Participants not able to follow study instructions

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Infectious Diseases Institute

Kampala, Uganda

Location

International Ctr for Excellence in Research and Rakai Health Sciences Program

Rakai, Uganda

Location

Related Publications (3)

• Stabinski L, Reynolds SJ, Ocama P, Laeyendecker O, Ndyanabo A, Kiggundu V, Boaz I, Gray RH, Wawer M, Thio C, Thomas DL, Quinn TC, Kirk GD; Rakai Health Sciences Program. High prevalence of liver fibrosis associated with HIV infection: a study in rural Rakai, Uganda. Antivir Ther. 2011;16(3):405-11. doi: 10.3851/IMP1783.

  PMID: 21555823 BACKGROUND

• Auerbach BJ, Reynolds SJ, Lamorde M, Merry C, Kukunda-Byobona C, Ocama P, Semeere AS, Ndyanabo A, Boaz I, Kiggundu V, Nalugoda F, Gray RH, Wawer MJ, Thomas DL, Kirk GD, Quinn TC, Stabinski L; Rakai Health Sciences Program. Traditional herbal medicine use associated with liver fibrosis in rural Rakai, Uganda. PLoS One. 2012;7(11):e41737. doi: 10.1371/journal.pone.0041737. Epub 2012 Nov 27.

  PMID: 23209545 BACKGROUND

• Redd AD, Wendel SK, Grabowski MK, Ocama P, Kiggundu V, Bbosa F, Boaz I, Balagopal A, Reynolds SJ, Gray RH, Serwadda D, Kirk GD, Quinn TC, Stabinski L. Liver stiffness is associated with monocyte activation in HIV-infected Ugandans without viral hepatitis. AIDS Res Hum Retroviruses. 2013 Jul;29(7):1026-30. doi: 10.1089/aid.2013.0004. Epub 2013 May 8.

  PMID: 23548102 BACKGROUND

MeSH Terms

Conditions

Hepatitis B; HIV Infections; Coinfection; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: October 27, 2008
• Study Completion: December 14, 2018
• Last Updated: December 5, 2019

Record last verified: 2018-12-14

Locations

UG (2)