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

August 6, 2009 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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 Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95814
        • University of California, Davis Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611-3015
        • Northwestern University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CD4 count
Time Frame: Throughout study
Throughout study
CD8 count
Time Frame: Throughout study
Throughout study
Laboratory and clinical adverse effects
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: David Asmuth, MD, Division of Infectious and Immunologic Diseases, University of California, Davis Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 25, 2004

First Submitted That Met QC Criteria

February 25, 2004

First Posted (Estimate)

February 26, 2004

Study Record Updates

Last Update Posted (Estimate)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5192
  • DAIDS-ES ID 10013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Pegylated interferon alfa-2a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe