NCT00002435已完成2 期
Study of the Activity of Thymic Humoral Factor (THF Gamma 2) on HIV Load in HIV-Positive Individuals With CD4+ Cell Counts in the Range of 200-500 Cells/mm3
Pharmacia19 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
- 19
研究概览
简要总结
To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.
详细描述
All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 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:
- •AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).
- •Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to < 200 cells/mm
- •Other marketed drugs as required.
- •Patients must have:
- •HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
- •No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.
- •Mean CD4 of 200-500 cells/mm
- •HIV-1 positive PCR RNA.
- •Ability to self-administer study drug by IM injection.
- •Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at >= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Malignancy.
- •Hematuria.
- •Proteinuria > 1+.
- •Concurrent Medication:
- •Non-antiretroviral agents with known or suspected activity against HIV.
- •Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.
- •Patients with the following prior conditions are excluded:
- •Myositis within the past 6 months.
- •Prior Medication:
- •Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.
- •Prior antiretroviral therapy (AZT-naive patients only).
- •Prior Treatment:
- •Excluded within 6 weeks prior to study entry:
- •Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
研究者
研究点 (19)
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