Hepatitis CLATHCVNCT01182298
Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
An observational study of Hepatitis C and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis C, HIV
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: latino with or without HIV infection undergoing Hepatitis C treatment
Who may be able to join
- A subject must satisfy all of the following criteria to be eligible to participate in this study:
- Latino ethnicity. Latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from Spanish-speaking countries in South and Central America, Mexico, and the Caribbean. Both parents and all grandparents of the participant have to be Latino, with Spanish as the primary language. Participants have to be white; native aboriginal Indians, Asians, and blacks will be excluded.
- Age greater than or equal to 18 years.
- Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL.
- Documentation of HIV-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV polymerase chain reaction positive.
- Participants with HIV: CD4+ cell counts greater than or equal to 100 cells/mm(3) or CD4+ cell percentage greater than or equal to 14%.
Show all 11Show fewer
- Ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies.
- Participants must have a primary care physician managing medical problems.
- For HIV infected participants, care provided by a primary physician must be consistent with the current DHHS guidelines. For those on therapy, HAART will be provided by their physician.
- Willing to undergo genetic testing
- About to start HCV treatment (with or without direct acting agents DAAs)
Who cannot join
- A subject will be ineligible to participate in this study if any of the following criteria are met:
- Unable to comply with research study visits
- Have any condition that the investigator considers a contraindication to study participation.
- Pregnant or breastfeeding women.
- Patients with poor venous access
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Study to Evaluate the Genetic, Epigenetic, and Proteomic Expression in Latino Participants With and Without HIV Coinfection Receiving Treatment for Hepatitis C
- Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV.
- Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection.
Objectives:
Read more
- To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection.
This is an observational study. The observed treatment is received and managed through their primary care.
Read the detailed description
Hepatitis C is a major health problem affecting 100- 300 million individuals worldwide. Chronic hepatitis C virus (HCV) infection leads to cirrhosis in approximately 20% of subjects over a period of 1-20 years. Hepatitis C is now the most common indication for liver transplantation in the United States. infection occurs in one-third of all HIV-infected individuals, and the natural history among HIV-1 infected individuals demonstrates higher levels of HCV viremia, faster rates of progression and cirrhosis. There have been very few studies addressing the lower therapeutic response rates in minorities outside of African Americans. A recent study showed that Latino white subjects respond less effectively (34%) than non Latino white subjects (49%) given the same treatment even after adjusting for various important factors. As the current landscape for treatment of HCV changes, it would be important to evaluate factors responsible for therapeutic response in Latino patients.
This is a study to address the genetic, epigenetic, and proteomic expression during therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. One hundred Latino participants who have evidence of chronic hepatitis C with and without HIV who are receiving treatment for HCV will be enrolled. The results of this study will enable us to explore reasons for the differential therapeutic response rates with Hepatitis C treatment in Latino participants with and without HIV coinfection.
- Conditions
- Hepatitis C, HIV
- Keywords
- Latino, HCV, pegIFN, Viral Kinetics, IL-28 Haplotype
- Medical subject headings
- Hepatitis C
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 |
|---|---|---|
| Hepatitis C | latino participants with Hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Log Change in HCV RNA Levels on Day 7
The primary end point of this study is the the log change in HCV RNA levels on Day 7
Measured: first 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: small number of patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- FDI Clinical Research
- Responsible party
- Sponsor
- Investigators
- Shyamasundaran Kottilil, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182298
- Sponsor's protocol ID
- 100159
- Other IDs
- 10-I-0159
- Acronym
- LATHCV
- Status last verified
- Sep 2014
- First submitted
- 13 Aug 2010
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Seeff LB, Hoofnagle JH. Appendix: The National Institutes of Health Consensus Development Conference Management of Hepatitis C 2002. Clin Liver Dis. 2003 Feb;7(1):261-87. doi: 10.1016/s1089-3261(02)00078-8.
PubMed 12691470Engels EA, Chatterjee N, Cerhan JR, Davis S, Cozen W, Severson RK, Whitby D, Colt JS, Hartge P. Hepatitis C virus infection and non-Hodgkin lymphoma: results of the NCI-SEER multi-center case-control study. Int J Cancer. 2004 Aug 10;111(1):76-80. doi: 10.1002/ijc.20021.
PubMed 15185346Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
PubMed 9121257
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Genetic, Epigenetic, and Proteomic Expression in Latino Participants With and Without HIV Coinfection Receiving Treatment for Hepatitis C
- ClinicalTrials.gov ID
- NCT01182298
- Acronym / sponsor ID
- LATHCV / 100159
- Conditions
- Hepatitis C, HIV
- Keywords
- Latino, HCV, pegIFN, Viral Kinetics, IL-28 Haplotype
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: small number of patients enrolled
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- FDI Clinical Research
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Posted 2 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV.
- Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection.
Objectives:
- To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection.
This is an observational study. The observed treatment is received and managed through their primary care.
Detailed description
Hepatitis C is a major health problem affecting 100- 300 million individuals worldwide. Chronic hepatitis C virus (HCV) infection leads to cirrhosis in approximately 20% of subjects over a period of 1-20 years. Hepatitis C is now the most common indication for liver transplantation in the United States. infection occurs in one-third of all HIV-infected individuals, and the natural history among HIV-1 infected individuals demonstrates higher levels of HCV viremia, faster rates of progression and cirrhosis. There have been very few studies addressing the lower therapeutic response rates in minorities outside of African Americans. A recent study showed that Latino white subjects respond less effectively (34%) than non Latino white subjects (49%) given the same treatment even after adjusting for various important factors. As the current landscape for treatment of HCV changes, it would be important to evaluate factors responsible for therapeutic response in Latino patients.
This is a study to address the genetic, epigenetic, and proteomic expression during therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. One hundred Latino participants who have evidence of chronic hepatitis C with and without HIV who are receiving treatment for HCV will be enrolled. The results of this study will enable us to explore reasons for the differential therapeutic response rates with Hepatitis C treatment in Latino participants with and without HIV coinfection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C | – | –latino participants with Hepatitis C |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- latino with or without HIV infection undergoing Hepatitis C treatment
Key inclusion criteria (11 listed)
- A subject must satisfy all of the following criteria to be eligible to participate in this study:
- Latino ethnicity. Latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from Spanish-speaking countries in South and Central America, Mexico, and the Caribbean. Both parents and all grandparents of the participant have to be Latino, with Spanish as the primary language. Participants have to be white; native aboriginal Indians, Asians, and blacks will be excluded.
- Age greater than or equal to 18 years.
- Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL.
- Documentation of HIV-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV polymerase chain reaction positive.
Key exclusion criteria (5 listed)
- A subject will be ineligible to participate in this study if any of the following criteria are met:
- Unable to comply with research study visits
- Have any condition that the investigator considers a contraindication to study participation.
- Pregnant or breastfeeding women.
- Patients with poor venous access
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
Median Log Change in HCV RNA Levels on Day 7
Time frame: first 7 days
The primary end point of this study is the the log change in HCV RNA levels on Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12691470Seeff LB, Hoofnagle JH. Appendix: The National Institutes of Health Consensus Development Conference Management of Hepatitis C 2002. Clin Liver Dis. 2003 Feb;7(1):261-87. doi: 10.1016/s1089-3261(02)00078-8.
- Background: PubMed 15185346Engels EA, Chatterjee N, Cerhan JR, Davis S, Cozen W, Severson RK, Whitby D, Colt JS, Hartge P. Hepatitis C virus infection and non-Hodgkin lymphoma: results of the NCI-SEER multi-center case-control study. Int J Cancer. 2004 Aug 10;111(1):76-80. doi: 10.1002/ijc.20021.
- Background: PubMed 9121257Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
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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.
Shyamasundaran Kottilil, 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 Hepatitis C and HIV, 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 11 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: stopped early, as of the sponsor's last update on 24 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Log Change in HCV RNA Levels on Day 7 (time frame: first 7 days). 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 NCT01182298, 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 24 Sep 2019.