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
Pegylated interferon alfa-2a
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: May 1, 2006
Actual date on which the first participant was enrolled.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 or who are ART naive. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Northwestern University
Chicago, United StatesDuke University Medical Center
Durham, United States