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The Safety and Effectiveness of r-HuEPO in Patients with AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic



The Safety and Effectiveness of r-HuEPO in Patients with AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic

For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Ortho Pharmaceuticals ,
Synopsis: To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.
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 HIV disease. - 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. Concurrent Medication: Excluded: - Zidovudine (AZT) during the double-blind phase of the study. Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS 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. - Zidovudine (AZT) and during double-blind phase of study. Clinical diagnosis of AIDS related anemia. - Clinical diagnosis of AIDS or advanced AIDS related complex (ARC). - Clinically stable for 1 month preceding study entry. Substance abuse.
Total Enrollment: 

Location and Contact Information:

Ortho Pharmaceutical Corp
Raritan,  New Jersey,  088690602
United States
 


Additional Information:
Study ID Numbers:  004D;  H87-048
Study Start Date: 
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002303

Other Hiv Infections Studies:
1. A Study of Disease Progression and Anti-HIV Treatments

2. Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

3. Growth Hormone in the Treatment of HIV-Associated Wasting

4. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies

5. Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults

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