Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias.
Concurrent Medication:
Excluded:
Antiretrovirals other than zidovudine (AZT) or Betaseron.
Chronic acyclovir therapy.
Acetaminophen.
Patients with the following are excluded:
Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to:
Intolerance at a dose of 500 to 600 mg/day.
Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study.
Prior Medication:
Excluded within 30 days of study entry:
Cytotoxic chemotherapy.
Prior therapy with alpha, beta, or gamma interferons.
Active drug or alcohol abuse.
Clareo Health | Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen