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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00078442 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Pegylated interferon alfa-2a |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 12 |
| Study Start Date: | May 2006 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, Davis Medical Center | |
| Sacramento, California, United States, 95814 | |
| United States, Illinois | |
| Northwestern University | |
| 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 |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | ACTG A5192, DAIDS-ES ID 10013 |
| Study First Received: | February 25, 2004 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00078442 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment Experienced Treatment Interruption Treatment Naive |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Infection Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections Interferon-alpha RNA Virus Infections Immune System Diseases |
Growth Substances Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Peginterferon alfa-2a Interferon Alfa-2a |