A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Patients performance on neuropsychological tests
研究概览
简要总结
To study the safety, toxicology, and activity of Peptide T (D-Ala-1-peptide-T-amide) in humans and to find out more about the ability of peptide T to prevent, halt, and/or reverse AIDS-associated immunologic disturbances.
Recent information suggests that the central nervous system (CNS) is often impaired in HIV-infected individuals. The dysfunction of the CNS may be either a direct or an indirect result of HIV infection. One method to prevent HIV infection is to block entry of the virus into the cells of the body. Peptide T shows laboratory evidence of blocking the entrance of HIV into cells that are susceptible to HIV infection. Studies that have been done indicate that peptide T is nontoxic in the doses that are used in this study.
AIDS patients with minimal (group 1) or moderate (group 2) cognitive dysfunction (mental impairment) receive an increasing schedule of three dosage levels of peptide T. All patients receive an intravenous (IV) dose of peptide T for 10 days followed by the intermediate dose and then the highest dose, each intravenously for 10 days. Following successful completion of 3 IV doses, four patients participate in an intranasal pharmacokinetic (blood level study) dosage trial of 3 doses (different from IV) of peptide T once for each of 3 successive days. Follow-up continues for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •History of either opportunistic infection and/or Kaposi's sarcoma, and/or serologic evidence of past infection with HIV. Ability to give informed consent.
- •Allowed but discouraged: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
- •Not breast-feeding
- •Abstinence or agree to use barrier methods of birth control / contraception during the study
- •Not pregnant
- •Negative pregnancy test
- •CD4 >= 200 cells/mm3 (200 - 300 - 400 - 500 - 600 - 700 - 800 plus).
- •Creatinine <= 1.6 mg/dl
- •Hemoglobin >= 12 g/dl
- •Platelet Count >= 100000 /mm3
排除标准
- •Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
- •Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
- •Excluded within 4 weeks of study entry:
- •Antiretroviral agents. Anticancer treatments. Psychoactive agents.
- •Excluded within 4 months of study entry:
- •Avoid: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
- •Excluded within 4 weeks of study entry:
- •Breast-feeding
- •Positive pregnancy test
- •No abstinence or no agreement to use barrier methods of birth control / contraception during the study
结局指标
主要结局
Patients performance on neuropsychological tests
时间窗: 10 days plus 10 days plus 3 days
The additional 3 days was for only 4 patients with follow-up for 1 year
次要结局
未报告次要终点