Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people currently on antiretroviral therapy (ART) interruption.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Pegylated interferon alfa-2a	Phase II

Further Study Details: 

Expected Total Enrollment:  12

IFN is an immune response enhancer and is produced in the body in response to viral infection. PEG-IFN may have less harmful side effects than non-pegylated IFN. Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment. PEG-IFN alfa-2a has demonstrated potentially useful antiviral properties in HIV treatment; however, due to the high doses that must be administered to maintain viral suppression, toxicity (especially to the blood) is a concern. This study will evaluate the safety, tolerability, and antiretroviral activity of PEG-IFN alfa-2a in HIV infected patients who have received ART in the past but are currently off ART.

The study will last 18 weeks. Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18. Physical exams will be performed weekly. Blood collection to monitor viral load, PEG-IFN alfa-2a serum levels, and CD4 and CD8 counts will be conducted at selected weeks during the study. Filgrastim will be given to patients who exhibit neutropenic toxicity.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• HIV infected
• CD4 count of 300 cells/ml or greater within 30 days of study entry
• HIV viral load of 5000 copies/ml or greater within 30 days of study entry
• Received antiretroviral therapy previously but have currently interrupted treatment within 12 weeks prior to study entry
• Willing to delay re-initiation of antiretroviral medications for the duration of the study
• Agree to use acceptable forms of contraception

Exclusion Criteria

• Previous use of interferon alfa
• Known allergy or sensitivity to PEG-IFN alfa-2a or its formulation
• Active drug or alcohol abuse that would interfere with the study
• Acute therapy for a serious infection within 30 days of study entry
• Use of non-protocol-specified immunomodulatory therapy within 60 days of study entry
• Active immunization within 30 days of study entry
• History of severe psychiatric disease such as major depression, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to psychiatric disease
• History of poorly controlled thyroid disease, including history of elevated thyroid stimulating hormone (TSH) levels with elevated antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
• History of clinically significant heart disease that could be worsened by acute anemia
• History of severe seizure disorder or current anticonvulsant use
• Hepatitis C antibody positive within 60 days prior to study entry
• Hepatitis B surface antigen positive within 60 days prior to study entry
• Known sensitivity to E. coli derived products, such as filgrastim
• Any past evidence of chronic liver disease
• Any past or current evidence of immunologically-mediated disease
• Evidence of chronic pulmonary disease
• Severe eye problems due to diabetes, hypertension, cytomegalovirus infection, or macular degeneration
• History of major organ transplantation with an existing functional graft
• History or other evidence of severe illness, cancer, or other conditions that would make the patient unsuitable for the study
• Hemoglobin abnormalities or any other cause of or tendency for breakdown of red blood cells
• Any medical condition that would prevent successful completion of the study
• Use of certain medications
• Pregnant or breastfeeding

California
      University of California, Davis Medical Center, Sacremento,  California,  95814,  United States; Recruiting
      UC Davis Medical Center, Sacremento,  California,  95814,  United States; Recruiting
Illinois
      Northwestern University, Chicago,  Illinois,  60611-3015,  United States; Recruiting

Study chairs or principal investigators

David Asmuth, MD,  Study Chair,  Division of Infectious and Immunologic Diseases, University of California, Davis Medical Center   

Study ID Numbers:  ACTG A5192
Record last reviewed:  March 2005
Last Updated:  April 7, 2005
Record first received:  February 25, 2004
ClinicalTrials.gov Identifier:  NCT00078442
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08