HIV InfectionsNCT00015652
Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN Alfa-2b), and Ribavirin (RBV) Treatment in Patients With Hepatitis C and HIV Coinfection
A study testing Ribavirin, Aldesleukin and Peginterferon alfa-2b in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in patients who also have HIV. The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- Ribavirin, Aldesleukin and Peginterferon alfa-2b
- How many people
- 24 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento Mar 2005
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are between 18 and 65 years of age.
- Are infected with HIV.
- Have been on the same anti-HIV drugs and doses, if on any, for 8 weeks or longer and intend to stay on these drugs the first 24 weeks of the study. If patients have not been on anti-HIV drugs, they should not start them during the first 24 weeks of the study.
- Have a CD4 count of 300 cells/mm3 or more within 30 days before study entry.
- Have an HIV viral load of less than 5,000 copies/ml within 30 days before study entry.
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- Have a detectable HCV viral load within 30 days before study entry.
- Have a chronic HCV infection at least 6 months before study entry.
- Can document chronic hepatitis within 24 months before study entry.
- Agree not to become pregnant (females) or make someone pregnant (males), or donate sperm, or participate in any other fertilization procedures while on the study drugs and for 6 months afterwards. Agree to use reliable forms of birth control during the same time period.
- Have a negative pregnancy test within 30 days of study entry.
Who cannot join
- Patients will not be eligible for this study if they:
- Have IgM antibody to hepatitis A within 30 days before study entry.
- Are coinfected with HBV within 30 days before study entry.
- Have had a liver biopsy showing liver disease (unless due to HCV) within 2 years before study entry.
- Have disease associated with the immune system such as Crohn's disease, ulcerative colitis, active rheumatoid arthritis, lupus, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, cryoglobulinemia with clinical manifestations including leukocytoclastic vasculitis, scleroderma, and severe psoriasis.
- Have severe cirrhosis of the liver.
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- Have significant heart problems.
- Have a thyroid problem which has not been treated.
- Have a history of severe mental problems.
- Have taken the following within 6 weeks before study entry: rifampin, rifabutin, pyrazinamide, isoniazid, G-CSF (filgrastim), GM-CSF (sargramostim), or ganciclovir.
- Have taken any of the following within 6 months before study entry: interleukins, interferons, therapeutic HIV vaccine, thalidomide, pentoxifylline, dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin inosiplex, polyribonucleoside, ditiocarb sodium, hydroxyurea, systemic corticosteroids, azathioprine, 6-mercaptopurine, cyclosporin A, or any investigational drug.
- Have taken interferon or ribavirin any time before study entry.
- Have a disease affecting the red blood cells.
- Have retinopathy (disease of the eye).
- Have a chronic liver disease other than HCV.
- Are pregnant or breast-feeding.
- Are allergic to IL-2, PEG-IFN alfa-2b, or RBV or other components of the study products.
- Are presently using illegal drugs.
- Have had more than 1 alcoholic drink per day during the previous 30 days before study entry, or more than 4 drinks per day during the previous 6 months.
- Have been treated for a serious infection or other serious medical illness within 14 days before study entry.
- Have uncontrolled seizures.
- Have serious breathing and lung problems.
- Have had a major organ transplantation.
- Have history of a severe medical problem that would make the patient unsuitable for the study.
- Have had treatment for cancer or treatment affecting the immune system within 24 weeks before study entry or expect to need such treatment at any time during the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Hospital CRS
Aurora, Colorado
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Northwestern University CRS
Chicago, Illinois, 60611
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, 75390
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, 52242
UCLA CARE Center CRS
Los Angeles, California, 90095
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, 10021
About this study
Official title: A Pilot Study of Low Dose Interleukin-2 (IL-2) With the Addition of Pegylated Interferon (PEG-IFN Alfa-2b) and Ribavirin (RBV) for the Treatment of Hepatitis C Infection in Subjects With HIV Coinfection
This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in patients who also have HIV.
The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study also will use IL-2, which is a substance that the body naturally produces. People with HIV infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it will "boost" the immune system's response to HCV. The FDA has approved IL-2 for the treatment of some cancers.
Read the detailed description
HCV infection is an increasingly important clinical problem in patients infected with HIV. In HIV-uninfected patients with acute HCV infection, the presence of vigorous T-cell proliferative responses to HCV proteins is associated with normalization of serum transaminase levels and viral clearance. Furthermore, early results suggest IL-2 may improve transaminase levels in HCV/HIV patients. These observations provide the rationale for an immune-based therapeutic approach to HCV/HIV coinfection. This study explores the use of initial immunostimulatory therapy with IL-2 followed by the addition of antiviral therapy with PEG-IFN alfa-2b and RBV, as a possible synergistic approach to treatment.
Patients receive IL-2 for 12 weeks followed by the addition of PEG-IFN alfa-2b and RBV at the Week 12 visit. Patients remain on IL-2, PEG-IFN alfa-2b, and RBV for an additional 48 weeks. At Week 60, all study treatment is permanently discontinued and patients continue to be evaluated through Week 84. Toxicity or intolerance is evaluated. Data is collected on biochemical and virologic responses.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- Ribavirin, Aldesleukin, Peginterferon alfa-2b
- Keywords
- Ribavirin, Polyethylene Glycols, Interferon Alfa-2b, Dose-Response Relationship, Drug, Drug Therapy, Combination, Antiviral Agents, Hepatitis C, Aldesleukin, Peginterferon
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
AldesleukinDrug
Peginterferon alfa-2bDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marshall Glesby, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015652
- Sponsor's protocol ID
- A5088
- Other IDs
- AACTG A5088, 10676, ACTG A5088
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2001
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Low Dose Interleukin-2 (IL-2) With the Addition of Pegylated Interferon (PEG-IFN Alfa-2b) and Ribavirin (RBV) for the Treatment of Hepatitis C Infection in Subjects With HIV Coinfection
- ClinicalTrials.gov ID
- NCT00015652
- Acronym / sponsor ID
- A5088
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- Ribavirin, Polyethylene Glycols, Interferon Alfa-2b, Dose-Response Relationship, Drug, Drug Therapy, Combination, Antiviral Agents, Hepatitis C, Aldesleukin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 2005 (actual)
- First posted
- 31 Aug 2001 (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.
This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in patients who also have HIV.
The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study also will use IL-2, which is a substance that the body naturally produces. People with HIV infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it will "boost" the immune system's response to HCV. The FDA has approved IL-2 for the treatment of some cancers.
Detailed description
HCV infection is an increasingly important clinical problem in patients infected with HIV. In HIV-uninfected patients with acute HCV infection, the presence of vigorous T-cell proliferative responses to HCV proteins is associated with normalization of serum transaminase levels and viral clearance. Furthermore, early results suggest IL-2 may improve transaminase levels in HCV/HIV patients. These observations provide the rationale for an immune-based therapeutic approach to HCV/HIV coinfection. This study explores the use of initial immunostimulatory therapy with IL-2 followed by the addition of antiviral therapy with PEG-IFN alfa-2b and RBV, as a possible synergistic approach to treatment.
Patients receive IL-2 for 12 weeks followed by the addition of PEG-IFN alfa-2b and RBV at the Week 12 visit. Patients remain on IL-2, PEG-IFN alfa-2b, and RBV for an additional 48 weeks. At Week 60, all study treatment is permanently discontinued and patients continue to be evaluated through Week 84. Toxicity or intolerance is evaluated. Data is collected on biochemical and virologic responses.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are between 18 and 65 years of age.
- Are infected with HIV.
- Have been on the same anti-HIV drugs and doses, if on any, for 8 weeks or longer and intend to stay on these drugs the first 24 weeks of the study. If patients have not been on anti-HIV drugs, they should not start them during the first 24 weeks of the study.
- Have a CD4 count of 300 cells/mm3 or more within 30 days before study entry.
- Have an HIV viral load of less than 5,000 copies/ml within 30 days before study entry.
Key exclusion criteria (25 listed)
- Have IgM antibody to hepatitis A within 30 days before study entry.
- Are coinfected with HBV within 30 days before study entry.
- Have had a liver biopsy showing liver disease (unless due to HCV) within 2 years before study entry.
- Have disease associated with the immune system such as Crohn's disease, ulcerative colitis, active rheumatoid arthritis, lupus, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, cryoglobulinemia with clinical manifestations including leukocytoclastic vasculitis, scleroderma, and severe psoriasis.
- Have severe cirrhosis of the liver.
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 |
|---|---|---|
| Ribavirin | Drug | – |
| Aldesleukin | Drug | – |
| Peginterferon alfa-2b | 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 1 Nov 2021.
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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.
Marshall Glesby study chair
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ribavirin, Aldesleukin and Peginterferon alfa-2b in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 11 inclusion and 25 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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 1 Nov 2021.