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 - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Interferon beta-1b Drug: Zidovudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002238
Responsible Party
Study ID Numbers ^ICMJE	002A, TBO1-310188
Study Sponsor ^ICMJE	Bayer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP