Search / Trial NCT00000844

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Drug Therapy, Combination Adjuvants, Immunologic Administration, Oral Acquired Immunodeficiency Syndrome Aids Related Complex Interferon Alpha

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.

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00000844_2023-12-10.pdf

4.5 MB

NCT00000844_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Detroit, Michigan, United States

New York, New York, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

New Haven, Connecticut, United States

Brooklyn, New York, United States

Nashville, Tennessee, United States

Redwood City, California, United States

Los Angeles, California, United States

Wilmington, Delaware, United States

Washington, District Of Columbia, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Valhalla, New York, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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