HIV InfectionNCT01296529
Study on Immunopathogenesis in HIV and Hepatitis C Coinfection
An observational study of HIV Infection and Hepatitis C Infection, run by Rush University Medical Center at 2 sites in United States.
Trial summary
Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+ cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for liver-related mortality in HIV-positive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Hepatitis C Infection, Fibrosis
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: a) HIV monoinfected; b) hepatitis C monoinfected; c) HIV/HCV coinfected untreated for hepatitis C; and d) HIV/HCV coinfected with clearance of HCV virus. Subjects will be all matched by age and estimated duration of hepatitis C infection where applicable. In addition, subjects in strata a and c will be matched by length of ARV therapy and CD4 count first established in strata d observed immediately before the initiation of successful hepatitis C therapy or documentation of negative HCV RNA in subjects with spontaneous clearance. Subjects in strata b will be matched in the same manner to strata d, except length of ARV therapy and CD4 count variables will not be considered. All subjects with HIV infection will be on HAART with undetectable viral loads.
Who may be able to join
- Strata a (n=15): Patients must be infected with HIV-1 infection without HCV. Evidence should include a copy of a laboratory report of testing positive for HIV antibodies and/or HIV viral RNA, and a negative antibody test for HCV
- Strata b (n=15): Patients must be infected with HCV infection without HIV. Evidence should include a copy of a laboratory report of testing positive for HCV antibodies and HCV viral RNA, and a negative antibody test for HIV
- Strata c (n=15): Patients must be co-infected with HIV \& HCV prior to enrollment. Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, and positive tests for HCV antibodies and HCV RNA.
- Strata d (n=15): Patients must be co-infected with HIV \& HCV prior to enrollment, with verification of successful treatment or spontaneous clearance for hepatitis C infection. Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, a positive tests for HCV antibodies, and undetectable HCV RNA without hepatitis C treatment (spontaneous clearance) or >6 months after hepatitis therapy (sustained virologic response)
- Patients should not have ESLD and/or HCC within 6 months of enrollment. Evidence should at least include a physical examination by certified medical practitioner, negative ultrasound of the liver, and laboratory testing consistent with Child A and a Model for ESLD (MELD) ≤ 10. (Note: patients taking atazanavir may be enrolled with elevated total bilirubin if other Child and MELD criteria are normal.)
- Treatment with antiretroviral drugs for at least 12 months
Show all 9Show fewer
- Undetectable HIV-1 RNA (<75 copies for at least 6 months)
- Patients must consent to study procedures
- Patients must be >18 years of age
Who cannot join
- Pregnancy
- History of End Stage Liver Disease
- Active hepatitis B infection
- Severe illness / discretion of investigator
- BMI ≥ 35
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
About this study
Official title: A Pilot Study on Immunopathogenesis in HIV and Hepatitis C Coinfection
Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+ cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals, patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis, which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death. Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue injury may offer an immunologic platform to determine factors associated with progressive liver fibrosis in coinfected patients. In this cross-sectional study we will evaluate whether HIV and HCV coinfection patients with well-controlled HIV infection who have an undetectable viral load exhibit abnormal levels of inflammation and immune activation, potentially contributing to advanced liver fibrosis. Comparative groups include coinfected patients successfully treated for hepatitis C, or who have absence of hepatitis C viremia through spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients with well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by non-invasive methods.
The primary objectives of this study are:
- To determine if there are differences in markers of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection.
- To assess the stage of liver fibrosis using non-invasive methods in subsets of patients with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver fibrosis with levels of inflammation and immune activation.
- Conditions
- HIV Infection, Hepatitis C Infection, Fibrosis, Inflammation
- Medical subject headings
- HIV Infections, Hepatitis C, Fibrosis, Inflammation
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 |
|---|---|---|
| HIV monoinfection | Evidence should include a copy of a laboratory report of testing positive for HIV antibodies and/or HIV viral RNA, and a negative antibody test for HCV | |
| HCV monoinfection | Evidence should include a copy of a laboratory report of testing positive for HCV antibodies and HCV viral RNA, and a negative antibody test for HIV | |
| HIV and HCV coinfection | Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, and positive tests for HCV antibodies and HCV RNA. | |
| HIV/HCV coinfection with HCV clearance | Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, a positive tests for HCV antibodies, and undetectable HCV RNA without hepatitis C treatment (spontaneous clearance) or >6 months after hepatitis therapy (sustained virologic response) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of liver fibrosis with levels of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection
Assess the associations between liver fibrosis as the dependent variable measured as a fibrosis score in kPa with predictor variables (markers of inflammation [IL-1β, IL-6, IL-8, IL10, IL-12, IL-15, IL-17, IL-21, IP10, IFN-γ, TNF-α, macrophage inflammatory protein 1 alpha (CCR7), hsCRP], immune activation and senescence [CD3, CD4, CD8, HLA DR, CD38, Ki67 CD45RA, CCR7, CD28, CD57], and tissue injury [tissue factor]) for groups b, c, and d separately by using linear regression models. Group a is the control arm for the dependent variable.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Rush University Medical CenterThe 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
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ruth M. Rothstein CORE Center, Merck Sharp & Dohme LLC, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Gregory Huhn, Rush University Medical Center
- Investigators
- Gregory Huhn, MD, MPHTM, Principal investigator, The Ruth M. Rothstein CORE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296529
- Sponsor's protocol ID
- 100517002
- Status last verified
- Dec 2012
- First submitted
- 26 Jan 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodowanec A, Brady KE, Gao W, Kincaid S, Plants J, Bahk M, Landay A, Huhn G. Differences in CD4+ T-cell Immune Activation in HIV, Hepatitis C (HCV), and HIV/HCV Coinfection Are Influenced by HIV and HCV Infection Status. Abstract MOPE011. 19th International AIDS Conference, Washington DC, July 23, 2012
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Immunopathogenesis in HIV and Hepatitis C Coinfection
- ClinicalTrials.gov ID
- NCT01296529
- Acronym / sponsor ID
- 100517002
- Conditions
- HIV Infection, Hepatitis C Infection, Fibrosis, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Ruth M. Rothstein CORE Center, Merck Sharp & Dohme LLC, University of North Carolina, Chapel Hill
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Feb 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.
Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+ cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals, patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis, which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death. Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue injury may offer an immunologic platform to determine factors associated with progressive liver fibrosis in coinfected patients. In this cross-sectional study we will evaluate whether HIV and HCV coinfection patients with well-controlled HIV infection who have an undetectable viral load exhibit abnormal levels of inflammation and immune activation, potentially contributing to advanced liver fibrosis. Comparative groups include coinfected patients successfully treated for hepatitis C, or who have absence of hepatitis C viremia through spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients with well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by non-invasive methods.
The primary objectives of this study are:
- To determine if there are differences in markers of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection.
- To assess the stage of liver fibrosis using non-invasive methods in subsets of patients with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver fibrosis with levels of inflammation and immune activation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV monoinfection | – | –Evidence should include a copy of a laboratory report of testing positive for HIV antibodies and/or HIV viral RNA, and a negative antibody test for HCV |
| HCV monoinfection | – | –Evidence should include a copy of a laboratory report of testing positive for HCV antibodies and HCV viral RNA, and a negative antibody test for HIV |
| HIV and HCV coinfection | – | –Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, and positive tests for HCV antibodies and HCV RNA. |
| HIV/HCV coinfection with HCV clearance | – | –Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, a positive tests for HCV antibodies, and undetectable HCV RNA without hepatitis C treatment (spontaneous clearance) or >6 months after hepatitis therapy (sustained virologic response) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a) HIV monoinfected; b) hepatitis C monoinfected; c) HIV/HCV coinfected untreated for hepatitis C; and d) HIV/HCV coinfected with clearance of HCV virus. Subjects will be all matched by age and estimated duration of hepatitis C infection where applicable. In addition, subjects in strata a and c will be matched by length of ARV therapy and CD4 count first established in strata d observed immediately before the initiation of successful hepatitis C therapy or documentation of negative HCV RNA in subjects with spontaneous clearance. Subjects in strata b will be matched in the same manner to strata d, except length of ARV therapy and CD4 count variables will not be considered. All subjects with HIV infection will be on HAART with undetectable viral loads.
Key inclusion criteria (9 listed)
- Strata a (n=15): Patients must be infected with HIV-1 infection without HCV. Evidence should include a copy of a laboratory report of testing positive for HIV antibodies and/or HIV viral RNA, and a negative antibody test for HCV
- Strata b (n=15): Patients must be infected with HCV infection without HIV. Evidence should include a copy of a laboratory report of testing positive for HCV antibodies and HCV viral RNA, and a negative antibody test for HIV
- Strata c (n=15): Patients must be co-infected with HIV \& HCV prior to enrollment. Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, and positive tests for HCV antibodies and HCV RNA.
- Strata d (n=15): Patients must be co-infected with HIV \& HCV prior to enrollment, with verification of successful treatment or spontaneous clearance for hepatitis C infection. Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, a positive tests for HCV antibodies, and undetectable HCV RNA without hepatitis C treatment (spontaneous clearance) or >6 months after hepatitis therapy (sustained virologic response)
- Patients should not have ESLD and/or HCC within 6 months of enrollment. Evidence should at least include a physical examination by certified medical practitioner, negative ultrasound of the liver, and laboratory testing consistent with Child A and a Model for ESLD (MELD) ≤ 10. (Note: patients taking atazanavir may be enrolled with elevated total bilirubin if other Child and MELD criteria are normal.)
Key exclusion criteria (5 listed)
- Pregnancy
- History of End Stage Liver Disease
- Active hepatitis B infection
- Severe illness / discretion of investigator
- BMI ≥ 35
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
Comparison of liver fibrosis with levels of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection
Time frame: 6 months
Assess the associations between liver fibrosis as the dependent variable measured as a fibrosis score in kPa with predictor variables (markers of inflammation [IL-1β, IL-6, IL-8, IL10, IL-12, IL-15, IL-17, IL-21, IP10, IFN-γ, TNF-α, macrophage inflammatory protein 1 alpha (CCR7), hsCRP], immune activation and senescence [CD3, CD4, CD8, HLA DR, CD38, Ki67 CD45RA, CCR7, CD28, CD57], and tissue injury [tissue factor]) for groups b, c, and d separately by using linear regression models. Group a is the control arm for the dependent variable.
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 12 Dec 2012.
- Results publicationHodowanec A, Brady KE, Gao W, Kincaid S, Plants J, Bahk M, Landay A, Huhn G. Differences in CD4+ T-cell Immune Activation in HIV, Hepatitis C (HCV), and HIV/HCV Coinfection Are Influenced by HIV and HCV Infection Status. Abstract MOPE011. 19th International AIDS Conference, Washington DC, July 23, 2012
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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.
Gregory Huhn, MD, MPHTM principal investigator
The Ruth M. Rothstein CORE Center
2 sites 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 Infection, run by Rush University Medical Center at 2 sites 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 9 inclusion and 5 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 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparison of liver fibrosis with levels of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection (time frame: 6 months). 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 NCT01296529, which also lists 1 linked publication.
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 12 Dec 2012.