NCT00002091已完成不适用
An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
PRIMARY: To determine whether pentoxifylline changes the self-reported measures of quality of life status, using measures of scores from double-blinded drug withdrawal and drug restart periods.
SECONDARY: To measure the changes in monthly CD4 counts, fasting serum triglyceride levels, and weight; to assess the safety of pentoxifylline in HIV-infected persons.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Stable antiretroviral therapy.
- •Maintenance medication for opportunistic infection.
- •Patients must have:
- •HIV positivity.
- •Patients on an antiretroviral must have received it for at least 2 months and have no currently perceived need to change or add to the regimen for the next 3 months.
- •Prior Medication:
- •Antiviral therapy (provided patient has been on such therapy for at least 2 months at study entry and dose is stable).
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy (only patients who are 30 days from a diagnosis of an opportunistic infection and on appropriate maintenance medication are allowed).
- •Known significant intolerance or hypersensitivity to theophylline, theobromine (chocolate), or caffeine, for reasons other than dyspepsia.
- •Inability to swallow tablets (gastric feeding tubes are allowed).
- •Active bleeding disorder or major bleeding source, including peptic ulcer or gastritis.
- •Any symptoms suggestive of concurrent illness that are not attributable to overall impairment by HIV or are not diagnosable based on the available evidence.
- •Not willing to comply with visit schedule and study procedures.
- •Concurrent Medication:
- •Concurrent use of the anticoagulant warfarin (Coumadin) and heparin.
- •Prior Medication:
- •Treatment with biologic response modifiers (e.g., interferon, interleukin) within 14 days prior to study entry.
- •Prior Treatment:
- •Major surgery within 30 days of study entry.
研究者
研究点 (1)
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