Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects
The purpose of this study is to see if it is safe to combine methadone with two HIV protease inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not currently taking PIs. This study will measure the interactions between methadone and the PIs.
Methadone is used treat addicts and to treat severe pain. In order to find the safest way to use methadone with PIs, it is important to evaluate how they interact.
研究概览
详细说明
Methadone is extensively used in the maintenance treatment of addicts and in the management of severe pain. In order to use methadone with HIV protease inhibitors correctly, it is important to evaluate and quantify interactions between the protease inhibitors and methadone.
Patients receive their usual daily dose of methadone followed with ritonavir and saquinavir, respectively, twice a day. Patients are evaluated on Day 4 for safety and tolerance, and their ritonavir dose is increased. On Day 8 patients are evaluated for a steady-state level of methadone. After 2 weeks of the protease inhibitor therapy, they return for methadone pharmacokinetic sampling at Day 15 over 24 hours. Both protease inhibitors and methadone are administered on Day 15 on an inpatient basis. On Day 30, patients are assessed for safety and tolerance.
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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California
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San Francisco、California、美国、941102859
- San Francisco Gen Hosp
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Colorado
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Denver、Colorado、美国、80262
- Univ of Colorado Health Sciences Ctr
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hosp
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New York
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New York、New York、美国、10003
- Beth Israel Med Ctr
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New York、New York、美国、10021
- Cornell Univ Med Ctr
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New York、New York、美国、10029
- Mount Sinai Med Ctr
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New York、New York、美国、10021
- Chelsea Ctr
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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
You may be eligible for this study if you:
- Are HIV-positive and have an HIV RNA count below 100,000 copies/ml within 30 days prior to study entry.
- Are taking methadone.
- Are at least 18 years old.
- Are within 40% of your ideal body weight and weigh at least 99 lbs.
Exclusion Criteria
You will not be eligible for this study if you:
- Are allergic to or are unable to take RTV or SQV.
- Have a history of treatment failure with indinavir, RTV, or SQV.
- Have a history of certain illnesses that might prevent you from completing the study.
- Have severe diarrhea or other stomach problems.
- Have taken any PI within 4 weeks prior to study entry.
- Would be unable to complete the study due to alcohol or drug abuse.
- Are co-enrolled in other protocols that have you taking medications that are prohibited in this study.
- Are taking PIs other than RTV or SQV.
- Are receiving certain therapies or are taking certain medications, including experimental drugs.
- Have an active opportunistic (AIDS-related) infection or disease that requires medication within 14 days prior to study entry.
- Are pregnant or breast-feeding.
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
调查人员
- 学习椅：Joseph Gal
出版物和有用的链接
研究记录日期
研究主要日期
研究完成 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ACTG 401
- 11357 (DAIDS ES)
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