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The Safety and Effectiveness of r-HuEPO in Patients with AIDS and Anemia Caused by AIDS and Treatment with AZT



The Safety and Effectiveness of r-HuEPO in Patients with AIDS and Anemia Caused by AIDS and Treatment with AZT

For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Ortho Pharmaceuticals ,
Synopsis: To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - History of any primary hematologic disease. - Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS. - AIDS-related dementia. - Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). - Presence of concomitant iron deficiency. - Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy. - Acute opportunistic infection. - History of seizures. Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded. - Patients who have previously participated in any other r-HuEPO clinical study are excluded. Prior Medication: Excluded within 30 days of study entry: - Experimental drug or experimental device. - Cytotoxic chemotherapy. - Excluded within 2 months of study entry: - Androgen therapy. Clinical diagnosis of AIDS related anemia. - Clinical diagnosis of AIDS. - Clinically stable for 1 month preceding study entry. - Maintenance dose of zidovudine (AZT) of at least 400 mg daily. Substance abuse.
Total Enrollment: 

Location and Contact Information:

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

Ortho Pharmaceutical Corp
Raritan,  New Jersey,  088690602
United States
 


Additional Information:
Study ID Numbers:
  004B;  87-021
Study Start Date: 
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002302

Other Cytopenias Studies:
1. An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex

2. Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults

3. A Study of Trimetrexate With Leucovorin Rescue for AIDS Patients Who Are Refractory to Standard Therapies for Pneumocystis carinii Pneumonia

4. A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)

5. A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

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The Safety and Effectiveness of r-HuEPO in Patients with AIDS and Anemia Caused by AIDS and Treatment with AZT

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