Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects

June 23, 2005 updated by: Interferon Sciences
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

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).
  • Didanosine (ddI)

Patients must have:

  • Seropositivity to HIV-1 by ELISA and Western blot.
  • At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
  • Written informed consent.
  • If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.

Prior Medication:

Allowed:

  • Zidovudine (AZT).
  • Didanosine (ddI)

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Major active opportunistic infection requiring active care within 2 weeks of study entry.
  • Evidence of chronic hepatitis with severe liver dysfunction:
  • albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
  • Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
  • Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.

Concurrent Medication:

Excluded:

  • Experimental medications other than didanosine (ddI).
  • Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
  • Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).

Patients with the following are excluded:

  • Asymptomatic at study entry.
  • Presence of antibodies to interferon due to prior therapy.
  • Hospitalization within 2 weeks of study entry.
  • Transfusion dependency.
  • Unwilling or unable to give informed consent.
  • Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
  • Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 6 weeks of study entry:

  • Interferons.
  • Excluded within 45 days of study entry:
  • Immunosuppressive agents.
  • Chemotherapy.
  • Steroids.
  • Immunomodulators.
  • Isoprinosine.
  • BCG vaccine.

Prior Treatment:

Excluded within 2 weeks of study entry:

  • Hospitalization.

Active intravenous (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

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

  • 069B
  • 90-355ME

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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