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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 Ctr New York, New York  10021
UCLA CARE Ctr Los Angeles, California  90095
George Washington Univ Med Ctr Washington, District of Columbia  20037
Rush Presbyterian - Saint Luke's Med Ctr Chicago, Illinois  60612
Northwestern Univ Med School Chicago, Illinois  60611
Boston Med Ctr Boston, Massachusetts  02118
Beth Israel Med Ctr / Peter Krueger Clinic New York, New York  10003
Univ Hosp of Cleveland / Case Western Reserve Univ Cleveland, Ohio  44106
Univ of South Florida Tampa, Florida  33612
Johns Hopkins Hosp Baltimore, Maryland  21287
Univ TX Galveston Med Branch Galveston, Texas  77550
USC School of Medicine / Norris Cancer Hosp Los Angeles, California  90033
Summitt Med Ctr / San Francisco Gen Hosp Oakland, California  94609
AIDS Research Consortium of Atlanta Atlanta, Georgia  30308
Chelsea Village Med Ctr New York, New York  10014
Dr Douglas Dieterich New York, New York  10016
Davies Med Ctr San Francisco, California  94114
Cedars Sinai Med Ctr Los Angeles, California  90048
Santa Clara Valley Med Ctr San Jose, California  951282699
Alta Bates / Herrick Hosp Berkeley, California  94704
UCI Med Ctr Orange, California  92668
Dr William Davis Washington, District of Columbia  20016
Graduate Hosp Philadelphia, Pennsylvania  19146
Thomas Jefferson Med College Philadelphia, Pennsylvania  19107
Saint Christopher's Hosp for Children Philadelphia, Pennsylvania  191341095