A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.

Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.

Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.

Study Type

Interventional

Enrollment

560

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
    • California
      • Los Angeles, California, United States, 90059
        • King - Drew Med Ctr
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
    • Connecticut
      • New Haven, Connecticut, United States, 065102483
        • Yale Univ / New Haven
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Med Ctr of Delaware / Wilmington Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
      • Washington, District of Columbia, United States, 20019
        • Abundant Life Clinic Foundation
      • Washington, District of Columbia, United States, 20059
        • Howard Univ Hosp
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota Hosp
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY / Health Sciences Ctr at Brooklyn
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Group / Harlem Hosp Ctr
      • New York, New York, United States, 10031
        • Dr Barbara Justice
      • Valhalla, New York, United States, 10595
        • New York Med College / Westchester County Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania Med Ctr
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Meharry Med College

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • Symptomatic HIV infection.
  • CD4 count 50 - 350 cells/mm3.

Prior Medication:

Allowed:

  • Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).
  • Maintenance therapy for a chronic condition.

Exclusion Criteria

Patients with the following prior condition are excluded:

  • Change in antiretroviral therapy within past 6 weeks.

Prior Medication:

Excluded:

  • Oral IFN-alpha or other immune-based therapy within the past month.
  • Therapy for any acute disease within the past week.

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Alston B
  • Study Chair: Standiford H
  • Study Chair: Kumi J
  • Study Chair: Greaves W

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 Completion (Actual)

June 1, 2002

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 (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DATRI 022
  • 11727 (Registry Identifier: DAIDS ES Registry Number)

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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