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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002238

Run by

Bayer

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).
• 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).

You may not qualify if…

• 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.

Where it is running

• Alta Bates / Herrick Hosp — Berkeley, California, United States
• USC School of Medicine / Norris Cancer Hosp — Los Angeles, California, United States
• Cedars Sinai Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Summitt Med Ctr / San Francisco Gen Hosp — Oakland, California, United States
• UCI Med Ctr — Orange, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Santa Clara Valley Med Ctr — San Jose, California, United States
• Dr William Davis — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of South Florida — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Chelsea Village Med Ctr — New York, New York, United States
• Dr Douglas Dieterich — New York, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Univ Hosp of Cleveland / Case Western Reserve Univ — Cleveland, Ohio, United States
• Thomas Jefferson Med College — Philadelphia, Pennsylvania, United States
• Saint Christopher's Hosp for Children — Philadelphia, Pennsylvania, United States
• Graduate Hosp — Philadelphia, Pennsylvania, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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