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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

18 Years
65 Years
Not Enrolling
HIV Infections, Hepatitis C

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Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

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

- 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

- 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.

Exclusion Criteria

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.

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Principal Investigator

Marshall Glesby

Investigator Role:

Study Chair


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

March 2005

Related Keywords:

  • HIV Infections
  • Hepatitis C
  • Ribavirin
  • Polyethylene Glycols
  • Interferon Alfa-2b
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Antiviral Agents
  • Hepatitis C
  • Aldesleukin
  • Peginterferon
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hepatitis
  • Hepatitis A
  • Hepatitis C



UCLA CARE Center CRS Los Angeles, California  90095
University of Colorado Hospital CRS Aurora, Colorado  80262
Northwestern University CRS Chicago, Illinois  60611
Univ. of Iowa Healthcare, Div. of Infectious Diseases Iowa City, Iowa  52242
Johns Hopkins Adult AIDS CRS Baltimore, Maryland  21287
Univ. of Cincinnati CRS Cincinnati, Ohio  45267
Weill Med. College of Cornell Univ., The Cornell CTU New York, New York  10021
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic Dallas, Texas  75390