HIV InfectionNCT01423643
HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
An observational study of HIV Infection and Hepatitis C, run by Johns Hopkins University at 1 site in United States.
Trial summary
The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV Infection, Hepatitis C
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with HIV and Hepatitis C in the metropolitan Baltimore area. Preference given to those enrolled in the Johns Hopkins Infectious Diseases Outpatient Clinic.
Who may be able to join
- Co-Infected Arm
- Subject must be an HIV/HCV co-infected adult with HIV infection diagnosed by antibody testing and chronic HCV infection diagnosed by reactive HCV antibody and detectable plasma HCV RNA.
- Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.
- Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- Subject must be able to provide informed written consent.
Show all 10Show fewer
- Control Arm
- Subject must have or be at risk of having medical conditions that increase the risk of liver disease. These include, but are not limited to, HIV mono-infection, HCV mono-infection, Hepatitis B infection, alcohol addiction, and/or non-alcoholic steatohepatitis.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- Subject must be able to provide informed written consent.
Who cannot join
- To avoid risks associated with ionizing radiation, female subjects may not be pregnant or breast feeding at the time of DEXA scanning. To avoid unknown risks to the fetus, female subjects may not be pregnant at the time of liver biopsy or FibroScan.
- To avoid interference with the DEXA scan, the subject may not have undergone a nuclear medicine exam with the past week and/or may not have undergone an x-ray procedure with contrast solution within the past 72 hours.
- To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.
Trial locations and contacts
1 site in 1 country.
About this study
The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART.
Read the detailed description
Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
- Conditions
- HIV Infection, Hepatitis C
- Keywords
- HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS Virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic, Hepatitis C virus, Hepatitis C antibodies, Hepatitis C antigens
- Medical subject headings
- HIV Infections, Hepatitis C, Acquired Immunodeficiency Syndrome, Hepatitis C, Chronic
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 |
|---|---|---|
| Main cohort | Adults infected with both HIV and Hepatitis C | |
| Control Group | Adults at risk for liver disease, but not infected with both HIV and Hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis stage
Liver histologic fibrosis stage (Ishak 0 - 6)
Measured: up to 15 years
Secondary outcomes (4)
Body composition
Body composition measurements, derived from DEXA
Measured: up to 15 years
Liver stiffness
Liver stiffness, derived from liver elastography
Measured: up to 15 years
Serum markers
Serum levels of various chemical markers
Measured: up to 15 years
Liver histology
Liver histology as described by a pathologist
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startMar 2001
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Prospective
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David Thomas, Johns Hopkins University
- Investigators
- David L. Thomas, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423643
- Sponsor's protocol ID
- NA00033421
- Other IDs
- R01DA013806
- Status last verified
- Feb 2016
- First submitted
- 23 Aug 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Salgado M, Kirk GD, Cox A, Rutebemberwa A, Higgins Y, Astemborski J, Thomas DL, Thio CL, Sulkowski MS, Blankson JN. Protective interleukin-28B genotype affects hepatitis C virus clearance, but does not contribute to HIV-1 control in a cohort of African-American elite controllers/suppressors. AIDS. 2011 Jan 28;25(3):385-7. doi: 10.1097/QAD.0b013e328341b86a.
PubMed 21099664Brown TT, Mehta SH, Sutcliffe C, Higgins Y, Torbenson MS, Moore RD, Thomas DL, Sulkowski MS. Hepatic steatosis associated with increased central body fat by dual-energy X-ray absorptiometry and uncontrolled HIV in HIV/hepatitis C co-infected persons. AIDS. 2010 Mar 27;24(6):811-7. doi: 10.1097/QAD.0b013e3283333651.
PubMed 20186036Balagopal A, Ray SC, De Oca RM, Sutcliffe CG, Vivekanandan P, Higgins Y, Mehta SH, Moore RD, Sulkowski MS, Thomas DL, Torbenson MS. Kupffer cells are depleted with HIV immunodeficiency and partially recovered with antiretroviral immune reconstitution. AIDS. 2009 Nov 27;23(18):2397-404. doi: 10.1097/QAD.0b013e3283324344.
PubMed 19773633Kirk GD, Astemborski J, Mehta SH, Spoler C, Fisher C, Allen D, Higgins Y, Moore RD, Afdhal N, Torbenson M, Sulkowski M, Thomas DL. Assessment of liver fibrosis by transient elastography in persons with hepatitis C virus infection or HIV-hepatitis C virus coinfection. Clin Infect Dis. 2009 Apr 1;48(7):963-72. doi: 10.1086/597350.
PubMed 19236273El-Maouche D, Mehta SH, Sutcliffe C, Higgins Y, Torbenson MS, Moore RD, Thomas DL, Sulkowski MS, Brown TT. Controlled HIV viral replication, not liver disease severity associated with low bone mineral density in HIV/HCV co-infection. J Hepatol. 2011 Oct;55(4):770-6. doi: 10.1016/j.jhep.2011.01.035. Epub 2011 Feb 19.
PubMed 21338640Woreta TA, Sutcliffe CG, Mehta SH, Brown TT, Higgins Y, Thomas DL, Torbenson MS, Moore RD, Sulkowski MS. Incidence and risk factors for steatosis progression in adults coinfected with HIV and hepatitis C virus. Gastroenterology. 2011 Mar;140(3):809-17. doi: 10.1053/j.gastro.2010.11.052. Epub 2010 Dec 4.
PubMed 21134375Sulkowski MS, Mehta SH, Torbenson MS, Higgins Y, Brinkley SC, de Oca RM, Moore RD, Afdhal NH, Thomas DL. Rapid fibrosis progression among HIV/hepatitis C virus-co-infected adults. AIDS. 2007 Oct 18;21(16):2209-16. doi: 10.1097/QAD.0b013e3282f10de9.
PubMed 18090048Mehta SH, Lucas GM, Mirel LB, Torbenson M, Higgins Y, Moore RD, Thomas DL, Sulkowski MS. Limited effectiveness of antiviral treatment for hepatitis C in an urban HIV clinic. AIDS. 2006 Nov 28;20(18):2361-9. doi: 10.1097/QAD.0b013e32801086da.
PubMed 17117023
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
- ClinicalTrials.gov ID
- NCT01423643
- Acronym / sponsor ID
- NA00033421
- Conditions
- HIV Infection, Hepatitis C
- Keywords
- HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS Virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2001
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Aug 2011 (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.
The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART.
Detailed description
Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main cohort | – | –Adults infected with both HIV and Hepatitis C |
| Control Group | – | –Adults at risk for liver disease, but not infected with both HIV and Hepatitis C |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with HIV and Hepatitis C in the metropolitan Baltimore area. Preference given to those enrolled in the Johns Hopkins Infectious Diseases Outpatient Clinic.
Key inclusion criteria (10 listed)
- Co-Infected Arm
- Subject must be an HIV/HCV co-infected adult with HIV infection diagnosed by antibody testing and chronic HCV infection diagnosed by reactive HCV antibody and detectable plasma HCV RNA.
- Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.
- Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
Key exclusion criteria (3 listed)
- To avoid risks associated with ionizing radiation, female subjects may not be pregnant or breast feeding at the time of DEXA scanning. To avoid unknown risks to the fetus, female subjects may not be pregnant at the time of liver biopsy or FibroScan.
- To avoid interference with the DEXA scan, the subject may not have undergone a nuclear medicine exam with the past week and/or may not have undergone an x-ray procedure with contrast solution within the past 72 hours.
- To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.
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
Fibrosis stage
Time frame: up to 15 years
Liver histologic fibrosis stage (Ishak 0 - 6)
4 secondary outcomes
Body composition
Time frame: up to 15 years
Liver stiffness
Time frame: up to 15 years
Serum markers
Time frame: up to 15 years
Liver histology
Time frame: up to 15 years
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 24 Feb 2016.
- Background: PubMed 21099664Salgado M, Kirk GD, Cox A, Rutebemberwa A, Higgins Y, Astemborski J, Thomas DL, Thio CL, Sulkowski MS, Blankson JN. Protective interleukin-28B genotype affects hepatitis C virus clearance, but does not contribute to HIV-1 control in a cohort of African-American elite controllers/suppressors. AIDS. 2011 Jan 28;25(3):385-7. doi: 10.1097/QAD.0b013e328341b86a.
- Background: PubMed 20186036Brown TT, Mehta SH, Sutcliffe C, Higgins Y, Torbenson MS, Moore RD, Thomas DL, Sulkowski MS. Hepatic steatosis associated with increased central body fat by dual-energy X-ray absorptiometry and uncontrolled HIV in HIV/hepatitis C co-infected persons. AIDS. 2010 Mar 27;24(6):811-7. doi: 10.1097/QAD.0b013e3283333651.
- Background: PubMed 19773633Balagopal A, Ray SC, De Oca RM, Sutcliffe CG, Vivekanandan P, Higgins Y, Mehta SH, Moore RD, Sulkowski MS, Thomas DL, Torbenson MS. Kupffer cells are depleted with HIV immunodeficiency and partially recovered with antiretroviral immune reconstitution. AIDS. 2009 Nov 27;23(18):2397-404. doi: 10.1097/QAD.0b013e3283324344.
- Background: PubMed 19236273Kirk GD, Astemborski J, Mehta SH, Spoler C, Fisher C, Allen D, Higgins Y, Moore RD, Afdhal N, Torbenson M, Sulkowski M, Thomas DL. Assessment of liver fibrosis by transient elastography in persons with hepatitis C virus infection or HIV-hepatitis C virus coinfection. Clin Infect Dis. 2009 Apr 1;48(7):963-72. doi: 10.1086/597350.
- Results publication: PubMed 21338640El-Maouche D, Mehta SH, Sutcliffe C, Higgins Y, Torbenson MS, Moore RD, Thomas DL, Sulkowski MS, Brown TT. Controlled HIV viral replication, not liver disease severity associated with low bone mineral density in HIV/HCV co-infection. J Hepatol. 2011 Oct;55(4):770-6. doi: 10.1016/j.jhep.2011.01.035. Epub 2011 Feb 19.
- Results publication: PubMed 21134375Woreta TA, Sutcliffe CG, Mehta SH, Brown TT, Higgins Y, Thomas DL, Torbenson MS, Moore RD, Sulkowski MS. Incidence and risk factors for steatosis progression in adults coinfected with HIV and hepatitis C virus. Gastroenterology. 2011 Mar;140(3):809-17. doi: 10.1053/j.gastro.2010.11.052. Epub 2010 Dec 4.
- Results publication: PubMed 18090048Sulkowski MS, Mehta SH, Torbenson MS, Higgins Y, Brinkley SC, de Oca RM, Moore RD, Afdhal NH, Thomas DL. Rapid fibrosis progression among HIV/hepatitis C virus-co-infected adults. AIDS. 2007 Oct 18;21(16):2209-16. doi: 10.1097/QAD.0b013e3282f10de9.
- Results publication: PubMed 17117023Mehta SH, Lucas GM, Mirel LB, Torbenson M, Higgins Y, Moore RD, Thomas DL, Sulkowski MS. Limited effectiveness of antiviral treatment for hepatitis C in an urban HIV clinic. AIDS. 2006 Nov 28;20(18):2361-9. doi: 10.1097/QAD.0b013e32801086da.
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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.
David L. Thomas, MD principal investigator
Johns Hopkins University
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 HIV Infection and Hepatitis C, run by Johns Hopkins University 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 10 inclusion and 3 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 24 Feb 2016. 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?
Fibrosis stage (time frame: up to 15 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 NCT01423643, which also lists 8 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 24 Feb 2016.