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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 | Clinical Trials | Clareo Health

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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

NCT00002238•Bayer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+14 more criteria

Locations (25)

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

Key Dates

Last Updated

June 24, 2005

Conditions

HIV Infections

Interventions

Interferon beta-1b

DRUG

Zidovudine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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