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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002012

Run by

Interferon Sciences

People needed

45

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mount Sinai Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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