Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00078442
First received: February 25, 2004
Last updated: August 6, 2009
Last verified: August 2009
  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 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: May 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Detailed Description:

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078442

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
Sponsors and Collaborators
Investigators
Study Chair: David Asmuth, MD Division of Infectious and Immunologic Diseases, University of California, Davis Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov Identifier: NCT00078442     History of Changes
Other Study ID Numbers: ACTG A5192, DAIDS-ES ID 10013
Study First Received: February 25, 2004
Last Updated: August 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Treatment Interruption
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014