NCT00001989已完成2 期
A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin
Genelabs Technologies8 个研究点 分布在 1 个国家开始时间: 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
- 发起方
- 试验地点
- 8
研究概览
简要总结
This study involves GLQ223 administration to patients who have not previously been exposed to it, but who have received at least 9 months of zidovudine therapy. Efficacy evaluations will include survival, opportunistic infections, T4 cell count, and assessments of viral load.
详细描述
The study will involve the randomization of patients with 200-500 T4 cells and AIDS or ARC to one of three treatment arms: zidovudine alone, GLQ223 alone, or GLQ223 plus zidovudine. Patients randomized to receive GLQ223 will receive an infusion every three weeks for 45 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone for PCP prophylaxis.
- •Chronic suppressive therapy for the following infections:
- •Toxoplasmosis (pyrimethamine, sulfadiazine, or clindamycin). Cryptococcosis (fluconazole). Candidiasis (ketoconazole). Herpes simplex virus (acyclovir). Mycobacterium avium (isoniazid, clofazimine, amikacin, rifampin, rifabutin, ethambutol, or other drug with written permission of the sponsor).
- •Patients whose CD4+ count falls below 200 at two consecutive measurements must receive prophylaxis for PCP and any other clinically indicated conditions.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •An active AIDS-defining opportunistic infection.
- •Evidence of AIDS dementia complex or active neurologic disease, including progressive multi-focal leukoencephalopathy (PML), poorly controlled seizure disorder or active CNS infection.
- •Any condition which in the Investigator's opinion is sufficient to prevent adequate compliance with the study.
- •Concurrent Medication:
- •Therapeutic agents specific for HIV disease that have not received FDA approval.
- •Biologic response modifiers, including interferon, interleukin-2 (IL-2), and leukocyte stimulating hormones (GM-CSF, G-CSF).
- •Patients with the following are excluded:
- •An active AIDS-defining opportunistic infection.
- •Evidence of AIDS dementia complex or active neurologic disease, including progressive multi-focal leukoencephalopathy (PML), poorly controlled seizure disorder or active CNS infection.
- •Participation in other clinical studies, including investigational therapy of HIV infection.
- •Any condition which in the Investigator's opinion is sufficient to prevent adequate compliance with the study.
- •History of prior use of GLQ223 or trichosanthin or presence of anti-GLQ223 serum IgG antibody as measured by Western blot.
- •Inability to provide written informed consent.
- •Prior Medication:
- •History of prior use of GLQ223 or trichosanthin or presence of anti-GLQ serum IgG antibody as measured by Western blot.
- •Excluded within 30 days prior to enrollment:
- •Use of unapproved therapeutic agents specific for HIV disease, including ddC.
- •Use of biologic response modifiers, including interferon, interleukin-2, and leukocyte stimulating hormones (GM-CSF, G-CSF).
- •Patients have the following:
- •HIV positive by ELISA with confirmation by Western blot.
- •Symptomatic with AIDS-Related Complex or AIDS by CDC classification.
- •History of zidovudine therapy at a dose equal to or more than 300 mg daily for at least 9 consecutive months immediately prior to entry into study.
- •CD4 count equal to or more than 200 and equal to or less than 500 (mean of 2 readings one week apart).
- •Ability to give informed consent.
- •Zidovudine therapy at a dose equal to or more than 300 mg daily for at least 9 months immediately prior to entry into the study.
研究者
研究点 (8)
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