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
NCT ID: NCT00002238
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Interferon beta-1b
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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TBO1-310188
Identifier Type: -
Identifier Source: secondary_id
002A
Identifier Type: -
Identifier Source: org_study_id