Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
研究概览
简要总结
To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.
详细描述
Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.
Twenty-seven AIDS patients with elevated TNF and less than 300 CD4 cells are given pentoxifylline 3 times a day for 8 weeks. If no significant changes are seen in virologic, immunologic, or related measures, 27 additional patients are given a higher dose of pentoxifylline 3 times a day for eight weeks.
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:
- •Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, at current dosage for the 8 weeks of study treatment.
- •Prophylaxis (e.g., aerosolized pentamidine, trimethoprim / sulfamethoxazole (TMP / SMX), dapsone for Pneumocystis carinii pneumonia (PCP) if CD4 cell count is < 200 cells/mm3
- •Concurrent maintenance therapy for opportunistic infections.
- •Prior Medication: Required:
- •Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, for at least 2 months.
- •Patients must have the following:
- •Diagnosis of AIDS.
- •Documented HIV seropositivity.
- •Ability to give informed consent and willingness to comply with visit schedule and all procedures.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Lymphoma or visceral Kaposi's sarcoma.
- •Active peptic ulcer or bleeding disorder.
- •Hemophilia. Known intolerance to pentoxifylline, theophylline, or caffeine.
- •Concurrent Medication:
- •Warfarin and heparin.
- •Biological response modifiers (e.g., erythropoietin, interferon, G-CSF, GM-CSF).
- •Cytotoxic chemotherapy.
- •Megestrol acetate. Corticosteroids.
- •Concurrent Treatment:
- •Radiation therapy. Blood products or transfusions.
- •Patients with the following are excluded:
- •Presence of an active opportunistic infection.
- •Major surgery within 30 days of study treatment.
- •Prior Medication:
- •Biological response modifiers (including interferon, interleukin), corticosteroids, or megestrol acetate within 14 days of first (screening) TNF level.
- •Erythropoietin dependency or within 30 days of study treatment.
- •Prior Treatment:
- •Transfusion or blood product dependency or use within 30 days of study treatment.