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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002012
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1993

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002012 on ClinicalTrials.gov Archive Site
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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
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Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Interferon alfa-n3
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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
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002012
069A, 90-151ME
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Interferon Sciences
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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