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.
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Food and Drug Administration
|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|