We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002012
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
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.
The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.
Interventional
Not Provided
Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Interferon alfa-n3
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002012
069A
90-151ME
Not Provided
Not Provided
Not Provided
Not Provided
Interferon Sciences
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
March 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP