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

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Bayer

Status and phase

Completed
Phase 3

Conditions

HIV Infections

Treatments

Drug: Zidovudine
Drug: Interferon beta-1b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002238
TBO1-310188
002A

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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