NCT00002314已完成2 期
A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have:
- •HIV seropositivity.
- •Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
- •No active opportunistic infection. NOTE:
- •Patients with CD4 count >= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
- •Life expectancy of at least 24 weeks.
- •Stable weight (+/- 2 kg) by 28 days prior to study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
- •Known or suspected hypersensitivity to benzodiazepines.
- •Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
- •Ongoing diarrhea (> two liquid stools per day).
- •Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
- •Alteration of mental status that may interfere with study compliance.
- •Concurrent Medication:
- •AZT, ddI, or ddC.
- •Experimental antiretrovirals.
- •Biologic response modifiers or immunomodulating agents (e.g., interferon).
- •Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
- •Ganciclovir.
- •Foscarnet.
- •H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
- •Omeprazole.
- •Benzodiazepines.
- •Any other investigational compound.
- •Ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma).
- •Cytotoxic chemotherapy (systemic and local).
- •Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
- •Paromomycin sulfate.
- •Chronic suppressive therapy for CMV and/or MAI.
- •Patients with the following prior condition are excluded:
- •History of serious adverse reactions to benzodiazepines.
- •Prior Medication:
- •Interferons or immune modulators within 4 weeks prior to study entry.
- •Prior systemic cytotoxic chemotherapy (patients with CD4 counts >= 200 cells/mm3 only).
- •Benzodiazepines within 14 days prior to study entry.
- •Intralesional chemotherapy for Kaposi's sarcoma within 2 weeks prior to study entry.
- •Therapy with antiretroviral drugs (including AZT, ddI, ddC, d4T) or investigational drugs within 14 days prior to study entry.
- •Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.
研究者
研究点 (2)
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