A Phase II Open-Label Pilot Trial of the Antiretroviral Activity, Safety, and Tolerability of Pegylated Interferon Alfa-2A (40KD) [PegasysTM] in HIV-1 Infected Subjects

Study start date: May 1, 2006

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 ART previously but have currently interrupted treatment within 12 weeks prior to study entry OR ART naive * Willing to delay initiation or 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