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Sponsor study identifier
Secondary identifiers
observational
6,303
1 country
2
Study Start
October 27, 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 14, 2018
Date type not reportedThis date has not been verified as actual or estimated.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2018
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 29, 2008
Actual (reported)October 31, 2008
Actual (reported)December 14, 2018
Date type not reportedThis date has not been verified as actual or estimated.
Liver fibrosis and hepatoxicity
Infectious Diseases Institute
Kampala, Uganda
International Ctr for Excellence in Research and Rakai Health Sciences Program
Rakai, Uganda
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.
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.
Steven J Reynolds, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
6,303 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
October 27, 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Study Completion
December 14, 2018
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 5, 2019
Record last verified: 2018-12-14
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Source: ClinicalTrials.gov.
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