Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Interferon beta-1b
Interferon-beta
Interferons
Zidovudine
Criteria
Inclusion Criteria

Concurrent Medication:

Allowed:

- Zidovudine (AZT).

Patient must have:

- Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks
before entry.

- Acceptable hepatic and renal function.

- AMENDED to delete the following sentence:

- Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

- Concurrent, ineffectively controlled opportunistic infections.

- Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy.

- Proteinuria of 2+ or greater.

- HIV encephalopathy.

- HIV wasting syndrome.

- New York Heart Classification III or IV.

- Uncontrolled angina pectoris.

- 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.