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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


Phase 3
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

002A

NCT ID:

NCT00002238

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Zidovudine
  • Interferon Type I
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
UCLA CARE CtrLos Angeles, California  90095
George Washington Univ Med CtrWashington, District of Columbia  20037
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Boston Med CtrBoston, Massachusetts  02118
Beth Israel Med Ctr / Peter Krueger ClinicNew York, New York  10003
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, Ohio  44106
Univ of South FloridaTampa, Florida  33612
Johns Hopkins HospBaltimore, Maryland  21287
Univ TX Galveston Med BranchGalveston, Texas  77550
USC School of Medicine / Norris Cancer HospLos Angeles, California  90033
Summitt Med Ctr / San Francisco Gen HospOakland, California  94609
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
Chelsea Village Med CtrNew York, New York  10014
Dr Douglas DieterichNew York, New York  10016
Davies Med CtrSan Francisco, California  94114
Cedars Sinai Med CtrLos Angeles, California  90048
Santa Clara Valley Med CtrSan Jose, California  951282699
Alta Bates / Herrick HospBerkeley, California  94704
UCI Med CtrOrange, California  92668
Dr William DavisWashington, District of Columbia  20016
Graduate HospPhiladelphia, Pennsylvania  19146
Thomas Jefferson Med CollegePhiladelphia, Pennsylvania  19107
Saint Christopher's Hosp for ChildrenPhiladelphia, Pennsylvania  191341095