HIV Infections Clinical Trial
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
NCT number | NCT00002238 |
Other study ID # | 002A |
Secondary ID | TBO1-310188 |
Status | Completed |
Phase | Phase 3 |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | AIDS Research Consortium of Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Hosp | Baltimore | Maryland |
United States | Alta Bates / Herrick Hosp | Berkeley | California |
United States | Boston Med Ctr | Boston | Massachusetts |
United States | Northwestern Univ Med School | Chicago | Illinois |
United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
United States | Univ Hosp of Cleveland / Case Western Reserve Univ | Cleveland | Ohio |
United States | Univ TX Galveston Med Branch | Galveston | Texas |
United States | Cedars Sinai Med Ctr | Los Angeles | California |
United States | UCLA CARE Ctr | Los Angeles | California |
United States | USC School of Medicine / Norris Cancer Hosp | Los Angeles | California |
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 | Summitt Med Ctr / San Francisco Gen Hosp | Oakland | California |
United States | UCI Med Ctr | Orange | California |
United States | Graduate Hosp | Philadelphia | Pennsylvania |
United States | Saint Christopher's Hosp for Children | Philadelphia | Pennsylvania |
United States | Thomas Jefferson Med College | Philadelphia | Pennsylvania |
United States | Davies Med Ctr | San Francisco | California |
United States | Santa Clara Valley Med Ctr | San Jose | California |
United States | Univ of South Florida | Tampa | Florida |
United States | Dr William Davis | Washington | District of Columbia |
United States | George Washington Univ Med Ctr | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
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