|
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 Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on 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 conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their 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 condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Treatment: Allowed: - Minimal local irradiation for tumors. Patients must have: - Diagnosis of AIDS or AIDS related complex (ARC). - Neutropenia, due either to zidovudine (AZT) or HIV infection. - Life expectancy = or > 6 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following: - Serum carotene less than 75 IU/ml. - Vitamin A level less than 75 IU/ml. - More than 4 foul-smelling or greasy stools per day. - Other criteria of malabsorption. - Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation. - Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection. Concurrent Medication: Excluded within 4 weeks of study entry: - Any investigational drug. - Immunomodulating agents. - Hormonal therapy. - Cytolytic chemotherapeutic agents. - Antiretroviral agent other than zidovudine (AZT). - Excluded within 4 months of study entry: - Suramin. - Excluded within 3 months of study entry: - Ribavirin. Patients with the following are excluded: - Significant malabsorption. - Tumor likely to require specific antitumor therapy during study. - Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions. - Uncorrected nutritional deficiencies that may contribute to neutropenia. - Hypersensitivity to zidovudine (AZT) or other nucleoside analogs. - Profound dementia or altered mental status that would prohibit the giving of informed consent. Prior Treatment: Excluded within 1 month of study entry: - Transfusion. - Excluded within 4 weeks of study entry: - Radiation therapy to greater than 100 cm2 body area. Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study. Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.
Total Enrollment:
Location and Contact Information:
Natl Cancer Institute
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 067A; 07936
Study Start Date:
Record last reviewed: January 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002006
Other Cytopenias Studies:
1. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
2. A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
3. Measuring HIV Quality of Care
4. Pharmacokinetics of Intermittent Isoniazid
5. A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
Related Studies:
Other Cytopenias Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
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
|
|
|
|
|
|
|
|
