NCT00002338已完成1 期
A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection
Glaxo Wellcome7 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 7
研究概览
简要总结
To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.
详细描述
Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Recommended:
- •PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
- •Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
- •Patients must have:
- •HIV infection.
- •CD4 count 200 - 500 cells/mm
- •No history of or current AIDS-defining indicator disease by CDC criteria.
- •No antiretroviral therapy within the past 6 months.
- •Consent of parent or guardian if less than 18 years of age.
排除标准
- •Co-existing Condition:
- •Patient with the following symptoms or conditions are excluded:
- •Current evidence of chronic hepatitis of any etiology.
- •Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
- •Concurrent Medication:
- •Cytotoxic chemotherapy.
- •Other antiretroviral drugs.
- •Immunomodulators.
- •Foscarnet.
- •GM-CSF or G-CSF.
- •Erythropoietin.
- •Concurrent Treatment:
- •Radiation therapy.
- •Patients with the following prior conditions are excluded:
- •History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.
- •Prior Medication:
- •Excluded within the past 6 months:
- •Any antiretroviral therapy.
- •HIV immunotherapeutic vaccine.
- •Excluded within the past 4 weeks:
- •Cytotoxic chemotherapy.
- •Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.
- •Prior Treatment:
- •Excluded within the past 4 weeks:
- •Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.
研究者
研究点 (7)
Loading locations...
相似试验
已完成
1 期
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)HIV InfectionsHIVNCT00850616Merck Sharp & Dohme LLC147
已完成
1 期
A Study of the Safety, Tolerability, and Pharmacodynamics of MK-8931 in Participants With Alzheimer's Disease (MK-8931-010 AM1 [P07820 AM1])Alzheimer's DiseaseNCT01496170Merck Sharp & Dohme LLC32
招募中
1 期
A Phase I Study of LX22001 for Injection in Healthy SubjectsHealthyNCT06561542Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.70
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)Cancer, AdvancedNCT00750178Merck Sharp & Dohme LLC30
已完成
1 期
APG-1387 Study of Safety, Tolerability ,PK/PD in Patients With Chronic Hepatitis BChronic Hepatitis BNCT03585322Ascentage Pharma Group Inc.49