FibrosisNCT01524562
HIV Accelerated Liver Disease in Uganda
An observational study of Fibrosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Liver disease is a leading cause of death in people who have the human immunodeficiency virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most research on HIV-related liver disease has been conducted in North America and Europe. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis
- How many people
- 786 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2011to 17 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older
- Persons who are able and willing to provide informed consent
- Persons who have a transient elastography score >=9.0 kPa or have other evidence of liver disease, and who are willing to undergo an ultrasound and liver biopsy
- Other evidence of liver disease: Persons with an LSM <9.0 kPa who demonstrate liver transaminases at least 2-times greater than the upper limit of normal; those with persistently abnormal liver
- transaminases over a period of three months during the year preceding enrollment; those who show abnormalities on their ultrasound; those with other laboratory tests indicating the possibility of liver disease; and/or those who have a clinical or medical indication for a liver biopsy.
- Persons who are willing to have tissue samples undergo genetic testing
- Persons who agree to have samples stored for the purpose of future research
Who cannot join
- Women who are pregnant
- Persons with a cardiac device (i.e., pacemaker)
- Participants who are not able to follow study instructions
- Safety laboratory data indicating possible excess risk of bleeding including platelets <75,000 and an INR>=1.5. These safety laboratory values will be ascertained by obtaining a Complete Blood Count (CBC) and a Prothrombin Time (PT).
- Evidence of decompensated liver disease including ascites, or hepatic encephalopathy
- Persons who have any condition deemed, by the investigators, to be a contraindication to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
Bethesda, Maryland, 20892
About this study
Official title: HIV-Accelerated Liver Disease in Uganda
Background:
- Liver disease is a leading cause of death in people who have the human immunodeficiency virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most research on HIV-related liver disease has been conducted in North America and Europe. However, HIV-related liver disease in Uganda and other African nations may involve other diseases that are not common in the West, and may not involve hepatitis B or C. Researchers want to study HIV-related liver disease in Uganda to learn more about the differences between Western and African trends of this disease.
Read more
Objectives:
- To study HIV-related liver disease in rural Uganda.
Eligibility:
- Individuals at least 18 years of age who were tested for possible liver disease. Some participants will have HIV infection; others will be uninfected.
- All participants will be from rural areas of Uganda.
Design:
- Participants will have at least two study visits.
- Participants will have a physical exam and medical history. They will complete a questionnaire about health and quality of life. Blood, urine, and stool samples will be collected. Participants will also have a liver scan to check for liver scarring, and an ultrasound to take images of the liver.
- Participants who may have liver disease will visit a local hospital for more tests. A liver biopsy will be performed to collect liver tissue samples.
Read the detailed description
With improved survival following the introduction of highly active antiretroviral therapy (HAART), liver disease has become a leading cause of death among HIV-infected persons in Western cohorts, primarily affecting those co-infected with hepatitis B or C viruses (HBV, HCV). However, data are sparse on liver disease in HIV-infected populations from Uganda and other African nations, where the etiologies of liver disease are broader and include aflatoxin, schistosomiasis and other infectious and environmental agents. Our previous noninvasive study in rural, Rakai, Uganda indicates that the prevalence of significant liver fibrosis is high among HIV-infected individuals (17%) and is 50% higher than in HIV-uninfected persons, although the prevalence of viral hepatitis B co-infection is low (5%). The study presented here is a biopsy-based study that follows up on these results with the objectives of defining the etiology of liver disease and describing the mechanisms of HIV-accelerated liver fibrosis in this setting.
- Conditions
- Fibrosis
- Keywords
- Fibrosis, Cirrhosis, Africa, Schistosomiasis, Aflatoxin, Liver Disease
- Medical subject headings
- Fibrosis, Schistosomiasis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rakai Community Cohort | HIV Patients | |
| Rakai HIV Care Program | HIV Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining the eriology of liver disease
Describe the etiologiges and compare the pathogenesis of liver fibrosis in HIV-infected and HIV-uninfected persons wirh evidence of liver disease in rural, Rakai Uganda.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study start20 Dec 2011
- Primary completion12 May 2015
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibrosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven J Reynolds, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524562
- Sponsor's protocol ID
- 999912037
- Other IDs
- 12-I-N037
- Status last verified
- Jan 2020
- First submitted
- 1 Feb 2012
- Last updated
- 6 Jan 2020
- Results posted
- No
Publications
Salmon-Ceron D, Lewden C, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene G; Mortality 2000 study group. Liver disease as a major cause of death among HIV infected patients: role of hepatitis C and B viruses and alcohol. J Hepatol. 2005 Jun;42(6):799-805. doi: 10.1016/j.jhep.2005.01.022.
PubMed 15973779Soriano V, Martin-Carbonero L, Garcia-Samaniego J, Puoti M. Mortality due to chronic viral liver disease among patients infected with human immunodeficiency virus. Clin Infect Dis. 2001 Nov 15;33(10):1793-5. doi: 10.1086/323009. No abstract available.
PubMed 11641832Lewden C, Salmon D, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene G; Mortality 2000 study group. Causes of death among human immunodeficiency virus (HIV)-infected adults in the era of potent antiretroviral therapy: emerging role of hepatitis and cancers, persistent role of AIDS. Int J Epidemiol. 2005 Feb;34(1):121-30. doi: 10.1093/ije/dyh307. Epub 2004 Nov 23.
PubMed 15561752
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-Accelerated Liver Disease in Uganda
- ClinicalTrials.gov ID
- NCT01524562
- Acronym / sponsor ID
- 999912037
- Conditions
- Fibrosis
- Keywords
- Fibrosis, Cirrhosis, Africa, Schistosomiasis, Aflatoxin, Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Dec 2011 (actual)
- Primary completion
- 12 May 2015 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Liver disease is a leading cause of death in people who have the human immunodeficiency virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most research on HIV-related liver disease has been conducted in North America and Europe. However, HIV-related liver disease in Uganda and other African nations may involve other diseases that are not common in the West, and may not involve hepatitis B or C. Researchers want to study HIV-related liver disease in Uganda to learn more about the differences between Western and African trends of this disease.
Objectives:
- To study HIV-related liver disease in rural Uganda.
Eligibility:
- Individuals at least 18 years of age who were tested for possible liver disease. Some participants will have HIV infection; others will be uninfected.
- All participants will be from rural areas of Uganda.
Design:
- Participants will have at least two study visits.
- Participants will have a physical exam and medical history. They will complete a questionnaire about health and quality of life. Blood, urine, and stool samples will be collected. Participants will also have a liver scan to check for liver scarring, and an ultrasound to take images of the liver.
- Participants who may have liver disease will visit a local hospital for more tests. A liver biopsy will be performed to collect liver tissue samples.
Detailed description
With improved survival following the introduction of highly active antiretroviral therapy (HAART), liver disease has become a leading cause of death among HIV-infected persons in Western cohorts, primarily affecting those co-infected with hepatitis B or C viruses (HBV, HCV). However, data are sparse on liver disease in HIV-infected populations from Uganda and other African nations, where the etiologies of liver disease are broader and include aflatoxin, schistosomiasis and other infectious and environmental agents. Our previous noninvasive study in rural, Rakai, Uganda indicates that the prevalence of significant liver fibrosis is high among HIV-infected individuals (17%) and is 50% higher than in HIV-uninfected persons, although the prevalence of viral hepatitis B co-infection is low (5%). The study presented here is a biopsy-based study that follows up on these results with the objectives of defining the etiology of liver disease and describing the mechanisms of HIV-accelerated liver fibrosis in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rakai Community Cohort | – | –HIV Patients |
| Rakai HIV Care Program | – | –HIV Patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- transaminases over a period of three months during the year preceding enrollment; those who show abnormalities on their ultrasound; those with other laboratory tests indicating the possibility of liver disease; and/or those who have a clinical or medical indication for a liver biopsy.
Key exclusion criteria (6 listed)
- Women who are pregnant
- Persons with a cardiac device (i.e., pacemaker)
- Participants who are not able to follow study instructions
- Safety laboratory data indicating possible excess risk of bleeding including platelets <75,000 and an INR>=1.5. These safety laboratory values will be ascertained by obtaining a Complete Blood Count (CBC) and a Prothrombin Time (PT).
- Evidence of decompensated liver disease including ascites, or hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Defining the eriology of liver disease
Time frame: 2 years
Describe the etiologiges and compare the pathogenesis of liver fibrosis in HIV-infected and HIV-uninfected persons wirh evidence of liver disease in rural, Rakai Uganda.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Background: PubMed 15973779Salmon-Ceron D, Lewden C, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene G; Mortality 2000 study group. Liver disease as a major cause of death among HIV infected patients: role of hepatitis C and B viruses and alcohol. J Hepatol. 2005 Jun;42(6):799-805. doi: 10.1016/j.jhep.2005.01.022.
- Background: PubMed 11641832Soriano V, Martin-Carbonero L, Garcia-Samaniego J, Puoti M. Mortality due to chronic viral liver disease among patients infected with human immunodeficiency virus. Clin Infect Dis. 2001 Nov 15;33(10):1793-5. doi: 10.1086/323009. No abstract available.
- Background: PubMed 15561752Lewden C, Salmon D, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene G; Mortality 2000 study group. Causes of death among human immunodeficiency virus (HIV)-infected adults in the era of potent antiretroviral therapy: emerging role of hepatitis and cancers, persistent role of AIDS. Int J Epidemiol. 2005 Feb;34(1):121-30. doi: 10.1093/ije/dyh307. Epub 2004 Nov 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Reynolds, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining the eriology of liver disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524562, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.