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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 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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. 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare possible for their 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 condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.

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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



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

For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. 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
Minimum Age/Maximum Age: 6 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT) on NIAID 86-C-175. Patients must have: - Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex. - Granulocytopenia (< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175. - Life expectancy > 3 months. - Functioning indwelling central venous access device in place. Prior Medication: Allowed within 48 hours of study entry: - Prophylactic antibiotics. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Critically ill or clinically unstable. - Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry. - Ongoing IV alimentation. - Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia. - Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection. - Malignancy likely to require systemic treatment during study. Patients with the following are excluded: - Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions. - Hypersensitivity to zidovudine (AZT) or any other nucleoside analog. Prior Medication: Excluded within 48 hours of study entry: - Antibiotics. - Excluded within 30 days of study entry: - Antiretroviral agents other than zidovudine (AZT). - Acyclovir. - Ganciclovir. - Any investigational drug. - Immunomodulating drugs. - Cytolytic chemotherapeutic agents. - Corticosteroids. - Immunoglobulin preparations. - Excluded within 4 months of study entry: - Suramin. Prior Treatment: Excluded within 6 months of study entry: - Bone marrow transplantation. - Excluded within 4 weeks of study entry: - Lymphocyte transfusions. - Radiation therapy.
Total Enrollment: 

Location and Contact Information:

Natl Cancer Institute / HIV / AIDS Malignancy Branch
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  067B;  206
Study Start Date: 
Record last reviewed: January 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002263

Other Hiv Infections Studies:
1. A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

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

3. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

4. 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

5. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

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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
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