Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
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 who are currently on antiretroviral therapy (ART) interruption or who have not started taking anti-HIV drugs.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- CD8 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Laboratory and clinical adverse effects [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
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.
Drug: Pegylated interferon alfa-2a
Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment
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.
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95814|
|United States, Illinois|
|Chicago, Illinois, United States, 60611-3015|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||David Asmuth, MD||Division of Infectious and Immunologic Diseases, University of California, Davis Medical Center|