NCT00002048已完成不适用
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
Glaxo Wellcome44 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
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 44
研究概览
简要总结
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- •Other significant, chronic underlying medical illness which would impair study completion.
- •Liver dysfunction as demonstrated by lab results.
- •Laboratory evidence of compromised bone marrow function.
- •Concurrent Medication:
- •Any other experimental agents.
- •Any probenecid-containing product.
- •Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
- •Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
- •Unexplained fever > 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
- •Unexplained diarrhea defined by = or > 2 liquid stools per day persisting for = or > 14 days or 15 days in any 30-day period.
- •OR History of secondary infections associated with AIDS related complex (ARC) including:
- •Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
- •Herpes zoster infection within 3 years.
- •Oral hairy leukoplakia at any time.
- •OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
- •Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
- •Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.
- •Prior Medication:
- •- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
- •Excluded within 4 weeks of study entry:
- •- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
- •Excluded within 3 months of study entry:
- •- Antiretroviral drugs or biologic response modifiers.
- •Excluded within 4 months of study entry:
- •- Systemic corticosteroids.
- •Patients must meet the following criteria:
- •HIV infection demonstrated by ELISA and confirmed by Western blot.
- •Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
- •Ability to give informed consent.
- •Willingness to be followed by the originating medical center for the entire 3-year duration of the study.
- •Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
排除标准
- 未提供
研究者
研究点 (44)
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