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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa-n3
Interferon alfa-n1
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Adjuvants, Immunologic, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon-alpha

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King - Drew Med Ctr
  • AIDS Community Research Consortium
  • Yale Univ / New Haven
  • Med Ctr of Delaware / Wilmington Hosp
  • Georgetown Univ Med Ctr
  • Abundant Life Clinic Foundation
  • Howard Univ Hosp
  • Henry Ford Hosp
  • Univ of Minnesota Hosp
  • SUNY / Health Sciences Ctr at Brooklyn
  • Dr Barbara Justice
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • New York Med College / Westchester County Med Ctr
  • Univ of Pennsylvania Med Ctr
  • Meharry Med College

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000844
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Adjuvants, Immunologic, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon-alpha

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
560 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon alfa-n3
Intervention Type
Drug
Intervention Name(s)
Interferon alfa-n1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alston B
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Standiford H
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kumi J
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Greaves W
Official's Role
Study Chair
Facility Information:
Facility Name
King - Drew Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Yale Univ / New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
065102483
Country
United States
Facility Name
Med Ctr of Delaware / Wilmington Hosp
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Abundant Life Clinic Foundation
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20019
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Univ of Minnesota Hosp
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Dr Barbara Justice
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
New York Med College / Westchester County Med Ctr
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Univ of Pennsylvania Med Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Meharry Med College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11363808
Citation
Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.
Results Reference
background
PubMed Identifier
11364607
Citation
Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.
Results Reference
background
PubMed Identifier
10634196
Citation
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.
Results Reference
result

Learn more about this trial

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

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