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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002238
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1991
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Interferon beta-1b
Drug: Zidovudine
Phase 3

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002238

Locations
United States, California
Alta Bates / Herrick Hosp
Berkeley, California, United States, 94704
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States, 94609
UCI Med Ctr
Orange, California, United States, 92668
Davies Med Ctr
San Francisco, California, United States, 94114
Santa Clara Valley Med Ctr
San Jose, California, United States, 95128
United States, District of Columbia
Dr William Davis
Washington, District of Columbia, United States, 20016
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Chelsea Village Med Ctr
New York, New York, United States, 10014
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, United States, 10003
Dr Douglas Dieterich
New York, New York, United States, 10016
United States, Ohio
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Graduate Hosp
Philadelphia, Pennsylvania, United States, 19146
Thomas Jefferson Med College
Philadelphia, Pennsylvania, United States, 19107
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Bayer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002238     History of Changes
Other Study ID Numbers: 002A, TBO1-310188
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Interferon Type I

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferon-beta
Interferons
Zidovudine
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Anti-HIV Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 20, 2014