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A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia Clinical research trials and A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia clinical trial. Human subjects frequently get the finest healthcare available for their A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia  A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Ortho Pharmaceuticals ,
Synopsis: To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.
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. - HIV disease related dementia. - Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). - Presence of concomitant iron deficiency. - Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy. - Acute opportunistic infection. - History of seizures. - Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease. Concurrent Medication: Excluded: - Zidovudine (AZT) therapy during the double-blind phase of study. 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. - HIV disease related dementia. - Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). - Presence of concomitant iron deficiency. 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) therapy and during the double-blind phase. Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia. - Clinical diagnosis of AIDS or ARC. - Clinically stable for 1 month preceding study entry. - Patients should preferably be transfusion dependent. Substance abuse.
Total Enrollment:
Location and Contact Information:
Ortho Pharmaceutical Corp
Raritan, New Jersey, 088690602
United States
Additional Information:
Study ID Numbers: 004F; 87-022
Study Start Date:
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002042
Other Hiv Infections Studies:
1. The Safety and Effectiveness of r-HuEPO in Patients with AIDS and Anemia Caused by AIDS and Treatment with AZT
2. A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients with AIDS or AIDS-Related Complex
3. A Phase I/II Pilot Study of Simultaneously Administered rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
4. An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients with AIDS Virus Infection and Leukopenia
5. A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
Related Studies:
Other HIV Infections Clinical Trials
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A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
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