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Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa-n3
Sponsored by
Interferon Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon Type I, Recombinant

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Patients must have: Diagnosis of AIDS related complex (ARC). Given written informed consent. Been receiving a dose of = or < 600 mg/day of zidovudine (AZT) at least 90 days prior to study entry IF they are currently taking AZT. Prior Medication: Allowed: Zidovudine (AZT) at a dose = or < 600 mg/day at least 90 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of AIDS-defining condition or evidence of AIDS dementia. Evidence of chronic hepatitis with severe liver dysfunction, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular or psychiatric disorder that would limit the subject's ability to complete the 12 weeks of the study period. Concurrent Medication: Excluded: Ketoconazole. Trimethoprim / sulfamethoxazole (TMP/SMX). Experimental medications. Patients with the following are excluded: Absolute CD4 count of < 100 or > 350 cells/mm3. Any disease or disorder listed in Patient Exclusion Co-existing Conditions. Unlikely or unable to comply with the requirements of the protocol. Unwilling or unable to give informed consent. Development of antibodies to interferon during prior interferon therapy that occurred > 3 months prior to study entry. Prior Medication: Excluded within 45 days of study entry: Immunomodulators (e.g., BCG vaccine, isoprinosine). Chemotherapy. Steroids. Excluded within 3 months of study entry: Interferon therapy. Active IV drug abuse.

Sites / Locations

  • Mount Sinai Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Interferon Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002012
Brief Title
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
Official Title
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Interferon Sciences

4. Oversight

5. Study Description

Brief Summary
To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of an orally administered low dose interferon alfa-n3 as an immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex (ARC) patients.
Detailed Description
The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon Type I, Recombinant

7. Study Design

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

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Patients must have: Diagnosis of AIDS related complex (ARC). Given written informed consent. Been receiving a dose of = or < 600 mg/day of zidovudine (AZT) at least 90 days prior to study entry IF they are currently taking AZT. Prior Medication: Allowed: Zidovudine (AZT) at a dose = or < 600 mg/day at least 90 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of AIDS-defining condition or evidence of AIDS dementia. Evidence of chronic hepatitis with severe liver dysfunction, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular or psychiatric disorder that would limit the subject's ability to complete the 12 weeks of the study period. Concurrent Medication: Excluded: Ketoconazole. Trimethoprim / sulfamethoxazole (TMP/SMX). Experimental medications. Patients with the following are excluded: Absolute CD4 count of < 100 or > 350 cells/mm3. Any disease or disorder listed in Patient Exclusion Co-existing Conditions. Unlikely or unable to comply with the requirements of the protocol. Unwilling or unable to give informed consent. Development of antibodies to interferon during prior interferon therapy that occurred > 3 months prior to study entry. Prior Medication: Excluded within 45 days of study entry: Immunomodulators (e.g., BCG vaccine, isoprinosine). Chemotherapy. Steroids. Excluded within 3 months of study entry: Interferon therapy. Active IV drug abuse.
Facility Information:
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Hassett J, Mendelsohn L. Effect of low dose oral interferon alfa-n3 (IFN) in ARC. Int Conf AIDS. 1993 Jun 6-11;9(1):494 (abstract no PO-B28-2151)
Results Reference
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Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients

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