NCT00002357已完成2 期
A Multicenter, Randomized, Double-Blinded, Dose-Escalation Study Evaluating the Safety and Antiretroviral Activity of HBY 097 Versus HBY 097 Plus AZT in Patients With Asymptomatic or Mildly Symptomatic HIV Infection
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 12
研究概览
简要总结
To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.
PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
详细描述
Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks.
PER AMENDMENT: Enrollment to the lowest dose cohort is completed.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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:
- •Treatment for opportunistic infection that develops on study.
- •Recommended:
- •PCP prophylaxis if CD4 count falls below 200 cells/mm
- •Patients must have:
- •HIV infection.
- •CD4 count 200 - 500 cells/mm
- •HIV-1 RNA PCR value of 10000 copies/ml or higher.
- •Asymptomatic or mildly symptomatic disease.
- •No past or current AIDS-defining event.
- •Consent of parent or guardian if less than legal age of consent.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Endocrine, hepatic, renal, or gastrointestinal disease.
- •Cardiovascular conduction disease.
- •Concomitant medical illness that may complicate study conduct or interpretation of results.
- •Other factors that may interfere with patient compliance.
- •Concurrent Medication:
- •Antiretroviral agents other than study drugs.
- •Oral contraceptives.
- •Cytotoxic chemotherapy.
- •Immunomodulators.
- •Antiproliferative agents.
- •Corticosteroids.
- •Anabolic steroids.
- •Estrogens.
- •Quinoxaline derivatives.
- •Concurrent Treatment:
- •Radiation therapy.
- •Patients with the following prior conditions are excluded:
- •History of hypersensitivity to quinoxaline derivatives or intolerance to AZT.
- •History of cardiovascular conduction disease.
- •Prior participation in this study or any study using HBY
- •Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion.
- •History of thyroid disease.
- •Prior Medication:
- •Excluded at any time:
- •Prior non-nucleoside reverse transcriptase inhibitors.
- •Excluded within 30 days prior to study entry:
- •Any antiretroviral therapy.
- •Oral contraceptives.
- •Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons.
- •Cytotoxic chemotherapeutic agents.
- •Other investigational drugs.
- •Excluded within 6 months prior to study entry:
- •Immunotherapeutic vaccine.
- •Prior Treatment:
- •Excluded within 30 days prior to study entry:
- •Radiation therapy.
- •An experimental device. Current ethanol or illicit drug abuse.
研究者
研究点 (12)
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