Chronic Hepatitis C Infection in HIV-Infected PersonsPhase 3NCT00215891
PEG-Interferon a-2b + Ribavirin for Treatment of Chronic HRN 005 Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon
A Phase 3 study testing PEG-Interferon a-2b + Ribavirin in people with Chronic Hepatitis C Infection in HIV-Infected Persons and HIV Infections, run by Hepatitis Resource Network at 1 site in United States.
Trial summary
Objectives: Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Infection in HIV-Infected Persons, HIV Infections
- What is being tested?
- PEG-Interferon a-2b + Ribavirin
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
Who may be able to join
- 5.2 Inclusion Criteria
- To be eligible for this trial, patients must have documentation of the following:
- 5.2.1 Written informed consent specific to this protocol obtained prior to screening and willingness to participate in and comply with the study.
- 5.2.2 Male and female patients >18 years of age.
- 5.2.3 Detectable plasma HCV-RNA by RT-PCR or other assay (bDNA).
- 5.2.4 HCV genotype result must be available at screening (historical determinations of genotype are acceptable).
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- 5.2.5 Evidence of HIV infection (reactive HIV antibody with Western blot confirmation).
- 5.2.6 Compensated liver disease with the following laboratory parameters at screening (results within 1 month of screening):
- Hemoglobin values of ³ 11 gm/dL
- WBC ³ 3,000/mm3
- Neutrophil count ³1,250/mm3
- Platelets ³ 70,000/mm3
- Prothrombin time £ 3 seconds prolonged compared to control, or equivalent INR ratio
- Bilirubin within 20% of the upper limit of normal (unless non-hepatitis related factors such as Gilbert's disease or the use of indinivir explains an indirect bilirubin rise).
- Albumin ³ 3.0 g/dL
- Serum creatinine £ 1.4 mg/dL
- Fasting blood sugar £ 115 mg/dL for non-diabetic patients
- Hemoglobin A1C £ 8.5% for diabetic patients (whether on medication and/or diet controlled)
- 5.2.7 Thyroid Stimulating Hormone (TSH) within normal limits or thyroid disease under clinical control (within 3 months of screening)
- 5.2.8 Alpha-fetoprotein (AFP) value within normal limits obtained within the prior year. For patients with results above the upper limit of normal but < 100 ng/mL both of the following are required:
- Alpha-fetoprotein value < 100 ng/mL obtained within 3 months prior to entry AND
- Ultrasound obtained within 3 months prior to entry that is negative for evidence of hepatocellular carcinoma.
- 5.2.9 CD4 T cell count and HIV RNA level (by RT-PCR) within 1 month of screening:
- CD4 <100 Eligible with HIV RNA <25,000 by RT-PCR
- CD4 > 100 - Eligible with any HIV RNA level by RT-PCR
- 5.2.10 Stable antiretroviral regimen of FDA-approved agents for at least 4 weeks prior to baseline.
- 5.2.11 Reconfirmation and documentation that all sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods [Norplant], medroxyprogesterone acetate [Depo-Provera], surgical sterilization, barrier method [diaphragm + spermicide], or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. Female patients must not breast feed during the treatment period and for 6 months after discontinuation of therapy. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative.
- 5.2.12 Reconfirmation and documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.
- 5.2.13 Anyone at high risk of coronary artery disease should have a stress test performed prior to entry. This would include, but not be limited to, patients over age 55 who have a history of ischemia or who have a significant history of hypertension, diabetes mellitus, obesity, smoking and/or strong family history of coronary artery disease. Patients with evidence of ischemia on resting or stress EKG, or a history of an arrhythmia, angina or a myocardial infarction within 12 months must be excluded.
- 5.2.14 Although recommended, liver biopsy is not required for study entry. However, if a liver biopsy has been obtained, within three years of the initial screening visit, the pathology report will be collected with other study data.
Who cannot join
- 5.3 Exclusion Criteria
- Patients meeting any of the following criteria are not eligible for this trial:
- 5.3.1 Inability or unwillingness to provide written informed consent specific to this protocol or unwillingness to participate in and comply with the study.
- 5.3.2 Previous therapy with interferon alfa.
- 5.3.3 Women with ongoing pregnancy or breast-feeding.
- 5.3.4 Male partners of women who are pregnant.
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- 5.3.5 Hypersensitivity to interferon or ribavirin.
- 5.3.6 Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
- 5.3.7 Any other causes for chronic liver disease other than chronic hepatitis C.
- 5.3.8 Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
- 5.3.9 Any known preexisting medical condition that could interfere with a patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- 5.3.10 Patients with evidence of ischemia upon stress testing (required for patients at risk of or with a history of coronary artery disease, ECG evidence of ischemia, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months).
- 5.3.11 Active or acute HIV-related opportunistic infection.
- 5.3.12 Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
- 5.3.13 History of major organ transplantation with an existing functional graft (including Bone Marrow Transplants)
- 5.3.14 History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- 5.3.15 Concomitant medication with, rifampin/rifampicin, rifabutin, pyrazinamide, isoniazid, ganciclovir, thalidomide, oxymetholone (Anadrolâ), and immunomodulatory treatments (including supraphysiologic doses of steroids).
- 5.3.16 Coadministration of didanosine (DDI, dideoxyadenosine 5'-triphosphate) and ribavirin is not recommended.
- 5.3.17 Evidence of alcohol and/or drug abuse within one year of entry. Patients on methadone programs are not excluded.
- 5.3.18 Inability to abstain from alcohol throughout the entire course of treatment and follow-up.
- 5.3.19 History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
- 5.3.20 History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231-1001
About this study
Official title: PEG-Interferon a-2b + Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon
Objectives:
Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy).
Read more
Secondary
- To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).
- To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24
Study Design:
All qualifying patients will enter the treatment phase and be dosed as follows:
Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus
Ribavirin:
- 800 mg (400 mg bid) if body weight < 65 kg
- 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg
- 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg
- 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg
At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:
- Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment.
- Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment.
Study Population:
300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy.
Dosage and Administration:
Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus
Ribavirin:
- 800 mg (400 mg bid) if body weight < 65 kg
- 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg
- 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg
- 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg
Efficacy Evaluations:
Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2b and Ribavirin dosages will be obtained.
Safety Evaluations:
- Assessment of laboratory evaluations
- vital signs
- incidence and severity of adverse experiences
- dose adjustments
- premature withdrawal for safety reasons
- progression of disease as measured by HCV viral load
- AIDS defining events
- Being tested
- PEG-Interferon a-2b + Ribavirin
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-Interferon a-2b + RibavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectives:
Primary
To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy).
Secondary outcomes (3)
Secondary
· To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).
· To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Infection in HIV-Infected PersonsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Hepatitis Resource Network
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated Therapeutics Group, Subsidiary of Schering-Plough
- Investigators
- Mark Sulkowski, MD, Principal investigator, Hepatitis Resource Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215891
- Sponsor's protocol ID
- HRN 005
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 25 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEG-Interferon a-2b + Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon
- ClinicalTrials.gov ID
- NCT00215891
- Acronym / sponsor ID
- HRN 005
- Keywords
- Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Hepatitis Resource NetworkUniversity, hospital or other
- Collaborators
- Integrated Therapeutics Group, Subsidiary of Schering-Plough
- First posted
- 22 Sep 2005 (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.
Objectives:
Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy).
Secondary
- To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).
- To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24
Study Design:
All qualifying patients will enter the treatment phase and be dosed as follows:
Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus
Ribavirin:
- 800 mg (400 mg bid) if body weight < 65 kg
- 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg
- 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg
- 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg
At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:
- Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment.
- Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment.
Study Population:
300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy.
Dosage and Administration:
Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus
Ribavirin:
- 800 mg (400 mg bid) if body weight < 65 kg
- 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg
- 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg
- 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg
Efficacy Evaluations:
Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2b and Ribavirin dosages will be obtained.
Safety Evaluations:
- Assessment of laboratory evaluations
- vital signs
- incidence and severity of adverse experiences
- dose adjustments
- premature withdrawal for safety reasons
- progression of disease as measured by HCV viral load
- AIDS defining events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 5.2 Inclusion Criteria
- 5.2.1 Written informed consent specific to this protocol obtained prior to screening and willingness to participate in and comply with the study.
- 5.2.2 Male and female patients >18 years of age.
- 5.2.3 Detectable plasma HCV-RNA by RT-PCR or other assay (bDNA).
- 5.2.4 HCV genotype result must be available at screening (historical determinations of genotype are acceptable).
Key exclusion criteria (22 listed)
- 5.3 Exclusion Criteria
- 5.3.1 Inability or unwillingness to provide written informed consent specific to this protocol or unwillingness to participate in and comply with the study.
- 5.3.2 Previous therapy with interferon alfa.
- 5.3.3 Women with ongoing pregnancy or breast-feeding.
- 5.3.4 Male partners of women who are pregnant.
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 |
|---|---|---|
| PEG-Interferon a-2b + Ribavirin | Drug | – |
Primary outcome
Objectives:
Primary
To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy).
3 secondary outcomes
Secondary
· To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).
· To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24
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 25 Oct 2005.
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.
Mark Sulkowski, MD principal investigator
Hepatitis Resource Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-Interferon a-2b + Ribavirin in people with Chronic Hepatitis C Infection in HIV-Infected Persons and HIV Infections, run by Hepatitis Resource Network 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 30 inclusion and 22 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 25 Oct 2005. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Objectives:. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2005.