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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
Official Title ^ICMJE	Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Interferon alfa-n3
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002012
Responsible Party
Study ID Numbers ^ICMJE	069A, 90-151ME
Study Sponsor ^ICMJE	Interferon Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1993
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP