NCT00000803已完成2 期
A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
National Institute of Allergy and Infectious Diseases (NIAID)32 个研究点 分布在 2 个国家目标入组 471 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 32
研究概览
简要总结
To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
详细描述
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •PCP prophylaxis for patients with CD4 count <= 200 cells/mm
- •Topical antifungal agents.
- •Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections.
- •Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis).
- •Acute or maintenance therapy for toxoplasmosis.
- •Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection.
- •rEPO and rG-CSF.
- •Antibiotics for bacterial infections (except rifampin and rifabutin).
- •Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone.
- •Concurrent Treatment:
- •Allowed for cutaneous Kaposi's sarcoma:
- •Localized radiation therapy.
- •Limited intralesional therapy.
- •Patients must have:
- •HIV infection.
- •CD4 count 100 - 500 cells/mm
- •Prior cumulative monotherapy of <= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma).
- •Considered to be unlikely to comply with study requirements.
- •Concurrent Medication:
- •Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF).
- •Rifampin.
- •Rifabutin.
- •Terfenadine.
- •Astemizole.
- •Loratadine.
- •Quinidine.
- •Digitoxin.
- •Systemic corticosteroids for more than 21 consecutive days.
- •Foscarnet.
- •Systemic cytotoxic chemotherapy for a malignancy.
- •Patients with the following prior conditions are excluded:
- •History of intolerance to AZT at <= 600 mg/day or ddI at <= 400 mg/day or discontinuation of either drug for toxicity.
- •History of intolerance to trifluoperazine or piperazine citrate (per amendment).
- •History of pancreatitis.
- •History of grade 2 or worse peripheral neuropathy.
- •Unexplained temperature >= 38.5 C on any 7 days within the past 30 days.
- •Chronic diarrhea on any 15 days during the past 30 days.
- •Prior Medication:
- •Prior foscarnet as induction or maintenance therapy.
- •Prior ddC or d4T.
- •Prior AZT/ddI in combination or taken separately at different times.
- •Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.).
- •Prior protease inhibitors (although patients from ACTG 282 are eligible).
- •HIV-1 vaccine within the past 21 days.
- •Acute treatment for a serious infection or for any opportunistic infection within the past 14 days.
- •Excluded within the past 30 days:
- •Interferon or interleukin.
- •Rifampin.
- •Rifabutin.
- •Terfenadine.
- •Astemizole.
- •Loratadine.
- •Recombinant EPO or G-CSF.
- •Hydroxyurea.
- •Any other investigational drug.
- •Active drug or alcohol use.
研究者
研究点 (32)
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