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
2 other identifiers
interventional
N/A
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
25 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1991
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (25)
Alta Bates / Herrick Hosp
Berkeley, California, 94704, United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609, United States
UCI Med Ctr
Orange, California, 92668, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Santa Clara Valley Med Ctr
San Jose, California, 95128, United States
Dr William Davis
Washington D.C., District of Columbia, 20016, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Univ of South Florida
Tampa, Florida, 33612, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003, United States
Chelsea Village Med Ctr
New York, New York, 10014, United States
Dr Douglas Dieterich
New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095, United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1991-04