NCT00002114已完成2 期
A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides
Free Radical Sciences0 个研究点目标入组 125 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
- 发起方
- 入组人数
- 125
研究概览
简要总结
To compare the efficacy and safety of orally administered Procysteine with placebo in HIV-infected patients who are receiving 1 of the following: (1) zidovudine (AZT) alone; (2) didanosine (ddI) alone; (3) AZT plus ddI; or (4) AZT plus zalcitabine (ddC).
详细描述
All patients must receive treatment with antiretroviral nucleosides in addition to study treatment. Patients are randomized equally into 1 of 3 outpatient dosage groups. Group 1 receives placebo; Group 2 receives a low dose of Procysteine; and Group 3 receives a higher dose of Procysteine. Patients receive study treatment for 6 months (total duration of patient participation is 30 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Antiretroviral nucleosides (AZT alone, ddI alone, AZT plus ddI, or AZT plus ddC). Regimen may be altered on or after Week
- •Appropriate topical treatment or local radiotherapy for KS.
- •Treatment or prophylaxis for opportunistic infections, including pentamidine, cotrimoxazole, acyclovir, fluconazole, etc., at the discretion of the investigator.
- •Patients must have:
- •Documented serologic evidence confirming HIV infection.
- •Ability to participate in an outpatient study for at least 26 weeks.
- •(a) diagnosis of AIDS or AIDS-Related Complex (ARC) with CD4 count of 50 - 300 cells/mm3, or (b) CD4 count of 50 - 200 cells/mm3 and no symptoms of AIDS (asymptomatic). (Note:
- •Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 count of 50 - 200 cells/mm3.)
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Evidence of organ involvement with CMV and/or positive blood cultures for Mycobacterium avium.
- •Life expectancy less than 26 weeks.
- •Malignancy or advancing Kaposi's sarcoma (KS) with advancing or unstable skin lesion, or known or suspected visceral disease which requires systemic cytotoxic, myelosuppressive chemotherapy.
- •Stage 2 or greater AIDS-dementia complex (ADC), defined as ability to perform basic activities of self-care but inability to work or maintain more demanding aspects of daily life as a result of an acquired decrease in cognitive CNS-related motor function characteristic of ADC.
- •Psychological or emotional problems that prevent adequate compliance with study therapy.
- •Concurrent Medication:
- •Daily Vitamin C dosage greater than 1,000 mg or daily Vitamin E dosage greater than 100 units.
- •N-acetylcysteine, cysteine, or glutathione.
- •Any investigational drug.
- •Systemic chemotherapy.
- •Patients with the following prior conditions are excluded:
- •History of organ involvement with cytomegalovirus (CMV) and/or positive blood cultures for Mycobacterium avium.
- •Intractable diarrhea, defined as greater than 4 bowel movements per day for at least 2 weeks.
- •History of seizures which have not been controlled with appropriate anticonvulsant medications within the previous 6 months.
- •Prior Medication:
- •Any investigational agent or biological response modifier (including interferon or corticosteroids) within 1 month of study entry.
- •Use of erythropoietin (EPO), G-CSF, or GM-CSF within 28 days of randomization.
- •Risk Behavior:
- •Active alcohol or drug abuse.
- •Antiretroviral nucleosides (AZT alone, ddI alone, AZT plus ddI, or AZT plus ddC) for at least 3 months prior to study entry.
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