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CompletedNCT00000844Updated Nov 3, 2021

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

An interventional study of Interferon alfa-n3 and Interferon alfa-n1 in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 15 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
560
Ages
13 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Drug Therapy, Combination
  • Adjuvants, Immunologic
  • Administration, Oral
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Interferon-alpha
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 560 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double
Enrollment
560 participants

Interventions

  • DrugInterferon alfa-n3
  • DrugInterferon alfa-n1
06

Study locations

15 sites
  • King - Drew Med Ctr
    Los Angeles, California 90059, United States
  • AIDS Community Research Consortium
    Redwood City, California 94063, United States
  • Yale Univ / New Haven
    New Haven, Connecticut 065102483, United States
  • Med Ctr of Delaware / Wilmington Hosp
    Wilmington, Delaware 19801, United States
  • Georgetown Univ Med Ctr
    Washington, District of Columbia 20007, United States
  • Abundant Life Clinic Foundation
    Washington, District of Columbia 20019, United States
  • Howard Univ Hosp
    Washington, District of Columbia 20059, United States
  • Henry Ford Hosp
    Detroit, Michigan 48202, United States
  • Univ of Minnesota Hosp
    Minneapolis, Minnesota 55455, United States
  • SUNY / Health Sciences Ctr at Brooklyn
    Brooklyn, New York 11203, United States
  • Dr Barbara Justice
    New York, New York 10031, United States
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    New York, New York 10037, United States
  • New York Med College / Westchester County Med Ctr
    Valhalla, New York 10595, United States
  • Univ of Pennsylvania Med Ctr
    Philadelphia, Pennsylvania 19104, United States
  • Meharry Med College
    Nashville, Tennessee 37208, United States
07

References and documents

Publications

  • Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5. PubMed 11363808 ↗
  • Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10. PubMed 11364607 ↗
  • Alston B, Ellenberg JH, Standiford HC, Muth K, Martinez A, Greaves W, Kumi J. A multicenter, randomized, controlled trial of three preparations of low-dose oral alpha-interferon in HIV-infected patients with CD4+ counts between 50 and 350 cells/mm(3). Division of AIDS Treatment Research Initiative (DATRI) 022 Study Group. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):348-57. doi: 10.1097/00126334-199912010-00005. PubMed 10634196 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000844
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 31, 2001
Completion
Jun 2002
Last update
Nov 3, 2021

Study contacts

Alston B
study chair
Standiford H
study chair
Kumi J
study chair
Greaves W
study chair
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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