NCT00002263已完成不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sandoz
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Zidovudine (AZT) on NIAID 86-C-
- •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-
- •Life expectancy > 3 months.
- •Functioning indwelling central venous access device in place.
- •Prior Medication:
- •Allowed within 48 hours of study entry:
- •Prophylactic antibiotics.
排除标准
- •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:
- •Prior Treatment:
- •Excluded within 6 months of study entry:
- •Bone marrow transplantation.
- •Excluded within 4 weeks of study entry:
- •Lymphocyte transfusions.
- •Radiation therapy.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
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 FeasibilityCytopeniasHIV InfectionsNCT00002006Sandoz
已完成
1 期
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and LeukopeniaCytopeniasHIV InfectionsNCT00002008Sandoz
已完成
3 期
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With ChemotherapyAnemiaNCT02767765Hoffmann-La Roche61
进行中（未招募）
2 期
A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)Squamous Cell CarcinomaNCT06041802Merck Sharp & Dohme LLC19
已完成
2 期
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)NCT01371305Biogen41