HIV InfectionsPhase 2NCT00055341
Treatment of Hepatitis C in Hemophilic Patients With HIV
A Phase 2 study testing Peginterferon alfa-2a and Ribavirin in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Infections, Hepatitis C, Hemophilia
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jun 2005
- Phase
- Phase 2
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hemophilia A or B
- Exposure to blood or blood products prior to 1987
- Participating in "The Second Multicenter Hemophilia Cohort Study (MHCS-II)"
- HCV reactive by second/third generation ELISA assay and/or RIBA
- HCV RNA positive (PCR or bDNA methods)
- Chronic hepatitis confirmed by liver biopsy within 6 months prior to study entry (Note: cirrhosis is not an exclusion factor)
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- HIV infection for coinfected group; HIV viral load of 10,000 copies/ml or less
- If on antiretroviral drugs, stable regimen for at least 8 weeks prior to study entry
- Acceptable methods of contraception
Who cannot join
- Hemoglobin less than 10 g/dl
- For HIV coinfected group, CD4 count less than 200 cells/mm3 at time of screening visit
- Previous interferon or ribavirin therapy
- Corticosteroids or immunomodulatory drugs within 3 months prior to study entry
- Hepatitis B (HBsAg reactive)
- Alpha-1 antitrypsin deficiency
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- Wilson's disease
- Hemochromatosis
- Autoimmune disorder
- Decompensated liver disease evidenced by encephalopathy, ascites, or variceal bleed
- Prothrombin Time greater than 3 seconds above normal (International Normalized Ratio [INR] greater than 1.3)
- Platelet count less than 90,000/microL
- Active thyroid disease (thyroid replacement with normal TSH permitted)
- Chronic renal insufficiency, defined as creatinine greater than 1.5 mg/dl
- Life-threatening disease processes that could preclude completion of trial
- Alcohol abuse that the local investigator feels would interfere with compliance
- Illicit recreational drug use or methadone use within 6 months of study entry
- Major depression with hospitalization or suicide attempt is a relative, but not absolute, contraindication to therapy based on timing, circumstances, and current stability as assessed by the investigator
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter, Phase II, Open Label, Controlled Trial Evaluating the Response of Hepatitis C Virus (HCV) to Pegylated Interferon Alpha-2A and Ribavirin in Hemophilic Patients With and Without Coinfection With the Human Immunodeficiency Virus (HIV)
Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.
Read the detailed description
Hemophiliacs with symptomatic disease often receive blood products to correct clotting factor deficiencies. Prior to routine use of heat inactivation and screening of donor blood for specific viral pathogens, hemophiliacs were routinely exposed to, and infected with, viruses such as hepatitis B (HBV), HCV, and HIV. Studies in hemophiliacs suggest several important findings that warrant further investigation, including: 1) hemophiliacs infected with HCV may have more rapid progression to liver failure and death; 2) pooled blood concentrate from multiple donors leads to a high risk of mixed infection; and 3) different clinical outcomes and altered immune responses of HIV coinfected hemophiliacs may enhance understanding of mutant virus selection and the associated clinical outcomes. The purpose of this trial is to determine response rates to PEG-interferon and ribavirin in hemophiliacs with HCV alone and with HCV/HIV coinfection.
Participants in this study will be followed for 48 weeks on treatment and up to 36 months after treatment. Participants in this study will be admitted to the Clinical Research Center for 2 days at the beginning of the study. Participants will have 3 additional study visits in the first week of the study. After that, study visits occur at Weeks 2, 4, 8, 12, 16, 24, 32, 40, and 48. The follow-up visits will be at 4, 12, and 24 weeks following the end of treatment. Study visits include a physical exam and blood tests. Patients who do not respond to treatment will be followed in a prospective cohort study for up to 3 additional years so that evolution of the virus and associated immune responses can be evaluated.
- Conditions
- HIV Infections, Hepatitis C, Hemophilia
- Being tested
- Peginterferon alfa-2a, Ribavirin
- Medical subject headings
- HIV Infections, Hepatitis C, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
RibavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2003 (estimated)
- Study startMar 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenneth E. Sherman, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055341
- Sponsor's protocol ID
- 1R01AI049508-01
- Other IDs
- 5R01AI049508-02
- Status last verified
- Dec 2006
- First submitted
- 25 Feb 2003
- Last updated
- 30 Jul 2008
- Results posted
- No
Publications
Shire NJ, Horn PS, Rouster SD, Stanford S, Eyster ME, Sherman KE; Multicenter Hemophilia Cohort HCV Study Group. HCV kinetics, quasispecies, and clearance in treated HCV-infected and HCV/HIV-1-coinfected patients with hemophilia. Hepatology. 2006 Nov;44(5):1146-57. doi: 10.1002/hep.21374.
PubMed 17058240Qin H, Shire NJ, Keenan ED, Rouster SD, Eyster ME, Goedert JJ, Koziel MJ, Sherman KE; Multicenter Hemophilia Cohort Study Group. HCV quasispecies evolution: association with progression to end-stage liver disease in hemophiliacs infected with HCV or HCV/HIV. Blood. 2005 Jan 15;105(2):533-41. doi: 10.1182/blood-2004-04-1452. Epub 2004 Sep 16.
PubMed 15374882
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter, Phase II, Open Label, Controlled Trial Evaluating the Response of Hepatitis C Virus (HCV) to Pegylated Interferon Alpha-2A and Ribavirin in Hemophilic Patients With and Without Coinfection With the Human Immunodeficiency Virus (HIV)
- ClinicalTrials.gov ID
- NCT00055341
- Acronym / sponsor ID
- 1R01AI049508-01
- Conditions
- HIV Infections, Hepatitis C, Hemophilia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2002
- Study completion
- Jun 2005
- First posted
- 27 Feb 2003 (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.
Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.
Detailed description
Hemophiliacs with symptomatic disease often receive blood products to correct clotting factor deficiencies. Prior to routine use of heat inactivation and screening of donor blood for specific viral pathogens, hemophiliacs were routinely exposed to, and infected with, viruses such as hepatitis B (HBV), HCV, and HIV. Studies in hemophiliacs suggest several important findings that warrant further investigation, including: 1) hemophiliacs infected with HCV may have more rapid progression to liver failure and death; 2) pooled blood concentrate from multiple donors leads to a high risk of mixed infection; and 3) different clinical outcomes and altered immune responses of HIV coinfected hemophiliacs may enhance understanding of mutant virus selection and the associated clinical outcomes. The purpose of this trial is to determine response rates to PEG-interferon and ribavirin in hemophiliacs with HCV alone and with HCV/HIV coinfection.
Participants in this study will be followed for 48 weeks on treatment and up to 36 months after treatment. Participants in this study will be admitted to the Clinical Research Center for 2 days at the beginning of the study. Participants will have 3 additional study visits in the first week of the study. After that, study visits occur at Weeks 2, 4, 8, 12, 16, 24, 32, 40, and 48. The follow-up visits will be at 4, 12, and 24 weeks following the end of treatment. Study visits include a physical exam and blood tests. Patients who do not respond to treatment will be followed in a prospective cohort study for up to 3 additional years so that evolution of the virus and associated immune responses can be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Hemophilia A or B
- Exposure to blood or blood products prior to 1987
- Participating in "The Second Multicenter Hemophilia Cohort Study (MHCS-II)"
- HCV reactive by second/third generation ELISA assay and/or RIBA
- HCV RNA positive (PCR or bDNA methods)
Key exclusion criteria (19 listed)
- Hemoglobin less than 10 g/dl
- For HIV coinfected group, CD4 count less than 200 cells/mm3 at time of screening visit
- Previous interferon or ribavirin therapy
- Corticosteroids or immunomodulatory drugs within 3 months prior to study entry
- Hepatitis B (HBsAg reactive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2a | Drug | – |
| Ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
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 30 Jul 2008.
- Results publication: PubMed 17058240Shire NJ, Horn PS, Rouster SD, Stanford S, Eyster ME, Sherman KE; Multicenter Hemophilia Cohort HCV Study Group. HCV kinetics, quasispecies, and clearance in treated HCV-infected and HCV/HIV-1-coinfected patients with hemophilia. Hepatology. 2006 Nov;44(5):1146-57. doi: 10.1002/hep.21374.
- Results publication: PubMed 15374882Qin H, Shire NJ, Keenan ED, Rouster SD, Eyster ME, Goedert JJ, Koziel MJ, Sherman KE; Multicenter Hemophilia Cohort Study Group. HCV quasispecies evolution: association with progression to end-stage liver disease in hemophiliacs infected with HCV or HCV/HIV. Blood. 2005 Jan 15;105(2):533-41. doi: 10.1182/blood-2004-04-1452. Epub 2004 Sep 16.
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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.
Kenneth E. Sherman, MD, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon alfa-2a and Ribavirin in people with HIV Infections and Hepatitis C, 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 9 inclusion and 19 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 30 Jul 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00055341, which also lists 2 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 30 Jul 2008.