NCT00002092已完成不适用
A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and 16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To establish a safety record for cimetidine use in HIV-positive patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •All FDA-approved medications, antiretrovirals, and PCP prophylaxis drugs, with the exception of warfarin (Coumadin).
- •Other self-prescribed medications available either over the counter or through buyer's clubs.
- •Patients must have:
- •HIV positivity.
- •Patients on an antiviral or immunomodulating drug must have received it for at least 2 months and have no intention to make clinical or therapeutic changes in the first 8 weeks (such as adding a new agent or discontinuing effective viral suppressive therapy) that may interfere with the study.
- •Patients who become pregnant after enrollment will be permitted to continue on study drug but must sign an additional informed consent indicating their awareness of the issues in taking a drug with limited safety data during pregnancy.
- •Prior Medication:
- •Antiviral and immunomodulating drugs, provided patient has been on such therapy for at least 2 months prior to study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Known intolerance or hypersensitivity to cimetidine.
- •Evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy.
- •Any symptoms suggestive of concurrent illness that are not attributable to overall impairment by HIV or are not diagnosable based on the available evidence.
- •Inability to swallow tablets (gastric feeding tubes are allowed).
- •Not willing to comply with visit schedule and study procedures.
- •Concurrent Medication:
- •Warfarin (Coumadin).
- •Prior Medication:
- •Excluded within 4 weeks prior to study entry:
- •cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid).
研究者
研究点 (1)
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