NCT00002021已完成不适用
An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Astra USA4 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 4
研究概览
简要总结
To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV maintenance foscarnet therapy in preventing recurrent disease. To confirm the pharmacokinetics of intermittent induction and maintenance IV regimens.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Cyclosporine.
- •Patients must have AIDS as defined by the CDC or be immunocompromised (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency). Patients must also have herpes simplex virus (HSV) infection documented by culture and in vitro resistance to acyclovir by standard laboratory susceptibility or suspected resistance to acyclovir after an acyclovir treatment failure in which acyclovir was administered for at least 2 weeks intravenously at doses of 30 mg/kg/day (or a comparative dose adjusted for renal insufficiency). In vitro susceptibility data must be pending in the latter case. Patients must be able to give informed consent. Patients < 18 years of age may participate with the consent of parent, guardian, or person with power of attorney, or through the provisions of state laws regarding emancipated minors. Patients must have expected survival of at least 6 months.
- •Prior Medication:
- •Cyclosporin.
- •Ganciclovir.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Known allergy to foscarnet.
- •Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
- •Concurrent Medication:
- •Any potentially nephrotoxic agent (except cyclosporine).
- •Immunomodulators.
- •Biologic response modifiers.
- •Investigational agents.
- •Patients with the following are excluded:
- •Known allergy to foscarnet.
- •Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
- •Prior Medication:
- •Excluded within 7 days of study entry:
- •Any potentially nephrotoxic agent (except cyclosporin).
- •Immunomodulators.
- •Biologic response modifiers.
- •Investigational agents.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other ImmunodeficienciesHIV InfectionsHerpes SimplexNCT00002272Astra USA
已完成
不适用
A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDSCytomegalovirus RetinitisHIV InfectionsNCT00002432Astra USA
Unknown
不适用
A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With GanciclovirCytomegalovirus RetinitisHIV InfectionsNCT00002301Astra USA
已完成
1 期
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional DiseaseHIV InfectionsNCT00000729National Institute of Allergy and Infectious Diseases (NIAID)10
已完成
不适用
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS PatientsCytomegalovirus RetinitisHIV InfectionsNCT00002039Astra USA