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
NCT ID: NCT00000844
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Interferon alfa-n3
Interferon alfa-n1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Alston B
Role: STUDY_CHAIR
Standiford H
Role: STUDY_CHAIR
Kumi J
Role: STUDY_CHAIR
Greaves W
Role: STUDY_CHAIR
Locations
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King - Drew Med Ctr
Los Angeles, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
Yale Univ / New Haven
New Haven, Connecticut, United States
Med Ctr of Delaware / Wilmington Hosp
Wilmington, Delaware, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Abundant Life Clinic Foundation
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Henry Ford Hosp
Detroit, Michigan, United States
Univ of Minnesota Hosp
Minneapolis, Minnesota, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States
Dr Barbara Justice
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States
Meharry Med College
Nashville, Tennessee, United States
Countries
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References
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Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.
Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.
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.
Other Identifiers
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11727
Identifier Type: REGISTRY
Identifier Source: secondary_id
DATRI 022
Identifier Type: -
Identifier Source: org_study_id