Clinical trial NCT00002238: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Interferon Type I
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates / Herrick Hosp
state: California
city: Los Angeles
country: United States
facility: USC School of Medicine / Norris Cancer Hosp
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Med Ctr
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: Oakland
country: United States
facility: Summitt Med Ctr / San Francisco Gen Hosp
state: California
city: Orange
country: United States
facility: UCI Med Ctr
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Med Ctr
state: California
city: Washington
country: United States
facility: Dr William Davis
state: District of Columbia
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Tampa
country: United States
facility: Univ of South Florida
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Boston Med Ctr
state: Massachusetts
city: New York
country: United States
facility: Beth Israel Med Ctr / Peter Krueger Clinic
state: New York
city: New York
country: United States
facility: Chelsea Village Med Ctr
state: New York
city: New York
country: United States
facility: Dr Douglas Dieterich
state: New York
city: New York
country: United States
facility: Mem Sloan - Kettering Cancer Ctr
state: New York
city: Cleveland
country: United States
facility: Univ Hosp of Cleveland / Case Western Reserve Univ
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Med College
state: Pennsylvania
city: Philadelphia
country: United States
facility: Saint Christopher's Hosp for Children
state: Pennsylvania
city: Philadelphia
country: United States
facility: Graduate Hosp
state: Pennsylvania
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
Study officials:
References: