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
The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of
the placebo controlled period are concluded successfully.
- 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.
- Zidovudine (AZT) at a dose = or < 600 mg/day at least 90 days prior to study entry.
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.
- 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.
Excluded within 45 days of study entry:
- Immunomodulators (e.g., BCG vaccine, isoprinosine).
- Excluded within 3 months of study entry:
- Interferon therapy. Active IV drug abuse.