A Study of 1592U89 in HIV-Infected Patients
A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects
研究概览
详细说明
Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
研究类型
注册
阶段
- 阶段1
联系人和位置
学习地点
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Illinois
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Evanston、Illinois、美国、60201
- Evanston Hosp / Clinical Pharmacology Unit
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Massachusetts
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Boston、Massachusetts、美国、02115
- Fenway Community Health Ctr / Research Dept
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New York
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Albany、New York、美国、12208
- Albany Med College / Albany Med Ctr Hosp
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Concurrent Medication:
Allowed:
Prophylaxis for opportunistic infections.
Patients must have:
- HIV-1 infection.
- CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
- No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
Concurrent Medication:
Excluded:
- Immunomodulating agents.
- Chemotherapeutic agents.
- Antiretroviral therapy. NOTE:
- Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior conditions are excluded:
- History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
- History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
Prior Medication:
Excluded:
- Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
- Antiretroviral therapy within 2 weeks prior to administration of study drugs.
Prior Treatment:
Excluded:
Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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