Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients

June 23, 2005 updated by: Interferon Sciences
To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of an orally administered low dose interferon alfa-n3 as an immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex (ARC) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.

Study Type

Interventional

Enrollment

45

Phase

  • Not Applicable

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
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr

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

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).

Patients must have:

  • Diagnosis of AIDS related complex (ARC).
  • Given written informed consent.
  • Been receiving a dose of = or < 600 mg/day of zidovudine (AZT) at least 90 days prior to study entry IF they are currently taking AZT.

Prior Medication:

Allowed:

  • Zidovudine (AZT) at a dose = or < 600 mg/day at least 90 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • History of AIDS-defining condition or evidence of AIDS dementia.
  • Evidence of chronic hepatitis with severe liver dysfunction, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular or psychiatric disorder that would limit the subject's ability to complete the 12 weeks of the study period.

Concurrent Medication:

Excluded:

  • Ketoconazole.
  • Trimethoprim / sulfamethoxazole (TMP/SMX).
  • Experimental medications.

Patients with the following are excluded:

  • Absolute CD4 count of < 100 or > 350 cells/mm3.
  • Any disease or disorder listed in Patient Exclusion Co-existing Conditions.
  • Unlikely or unable to comply with the requirements of the protocol.
  • Unwilling or unable to give informed consent.
  • Development of antibodies to interferon during prior interferon therapy that occurred > 3 months prior to study entry.

Prior Medication:

Excluded within 45 days of study entry:

  • Immunomodulators (e.g., BCG vaccine, isoprinosine).
  • Chemotherapy.
  • Steroids.
  • Excluded within 3 months of study entry:
  • Interferon therapy. Active IV drug abuse.

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
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

Interferon Sciences

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

  • Hassett J, Mendelsohn L. Effect of low dose oral interferon alfa-n3 (IFN) in ARC. Int Conf AIDS. 1993 Jun 6-11;9(1):494 (abstract no PO-B28-2151)

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 Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1993

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 069A
  • 90-151ME

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.

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