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A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia Clinical research trials and A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia. A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia  A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia
A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia
For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: To determine the safety, tolerability and maximum tolerated dose of SDZ ILE 964 administered by daily subcutaneous injections in patients infected with human immunodeficiency virus (HIV) who have cytopenias (low blood cell counts). To obtain information about the biologic effects of SDZ ILE 964 administration in improving blood counts in HIV-infected patients. To obtain information about the effects of SDZ ILE-964 administration on both parameters of HIV replication and on residual immunologic function.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV seropositivity by Western blot. - Advanced ARC or AIDS as defined by CDC. - Cytopenia defined as total peripheral leukocyte count of < 3,000 cells/mm3 or platelet count of < 100,000 cells/mm3 or serum hemoglobin < 10 g/dl. - Anticipated life expectancy = or > 6 months. - Ambulatory. - Willing to sign informed consent. - Willing to forego use of any other investigational therapies except ddI. Prior Medication: Allowed > 2 weeks prior to study entry: - zidovudine. - Allowed > 4 weeks prior to study entry: - systemic cytotoxic chemotherapy; investigational drugs; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone. - Allowed > 6 weeks prior to study entry: - other hemopoietic growth factor treatment as GM-CSF, EPO. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active opportunistic infection. - Symptoms of CNS disease referable to HIV infection. - Dementia or altered mental status that would prohibit giving and understanding informed consent. Systemic chemotherapy. - Investigational therapies other than ddI. - Medications with known myelosuppressive effects such as ganciclovir, trimethoprim/sulfamethoxazole or dapsone or AZT. - Other hematopoietic growth factor treatments as GM-CSF, G-CSF, or EPO. Prophylactic therapy for pneumocystis or oral thrush. - ddI. - Corticosteroids or topical corticosteroid creams. Patients may not have: - Life expectancy < 6 months. - Active drug or alcohol abuse. - Active opportunistic infections. - Treatment with any other investigational drugs except ddI within 4 weeks of study entry. - Dementia or altered mental state that prohibits giving informed consent. - Symptoms of CNS disease referable to HIV infection. - Major surgery within 4 weeks of study entry. - History of major pulmonary or cardiac disease. - History of any prior malignancy other than Kaposi's sarcoma or noninvasive subcutaneous carcinoma. - Documented allergic disorder such as asthma, history of anaphylaxis, atopy, serum sickness, or bronchospasm. Not allowed within 2 weeks prior to study entry: - zidovudine (AZT). - Not allowed within 4 weeks prior to study entry: - systemic cytotoxic chemotherapy; investigational drugs other than ddI; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone. - Not allowed within 6 weeks prior to study entry: - other hematopoietic growth factor treatment as GM-CSC, G-CSF, EPO. Radiation therapy or major surgery within 4 weeks of study entry. Active drug or alcohol abuse.
Total Enrollment:
Location and Contact Information:
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: 080A; B104
Study Start Date:
Record last reviewed: November 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002258
Other Cytopenias Studies:
1. 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
2. A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
3. 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
4. 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
5. A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
Related Studies:
Other Cytopenias Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia
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