A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Recombinant HIV-1 Vaccines in HIV-1 Infected Young Adults With Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy (HAART)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Development of any adverse events of Grade 3 or higher
研究概览
简要总结
The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy.
详细描述
By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-threatening, many patients find it difficult to tolerate a HAART regimen. HAART-associated long-term morbidity or mortality contribute to this difficulty. Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This study will evaluate the safety of two injections of two recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART.
This study will last 72 weeks. All participants will receive two rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and two rFPV vaccines (env/gag and tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over 72 weeks. A physical exam, blood collection, and administration of an adherence module will occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and 10. Urine collection will occur at study entry and Weeks 4, 8, and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected
- •CD4 count of 350 cells/mm3 or greater
- •If hepatitis B or C infected, infection must be chronic and stable
- •Normal electrocardiogram (ECG)
- •On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry
- •Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination.
- •Willing to follow all study requirements
- •Available for follow-up for the duration of the study
排除标准
- •History of allergic reaction to eggs or egg products
- •Known hypersensitivity to vaccine components
- •Chemotherapy for active cancer in the 12 months prior to study entry
- •Prior vaccination with any HIV-1 vaccine
- •Prior vaccination against smallpox
- •Prior vaccinia immunization
- •Any immunization within 1 month of study screening
- •History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care
- •Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry
- •Systemic steroids, including nonprescription street steroids, within 6 months of study entry
- •Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition
- •Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study
- •Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study
- •Pregnancy or breastfeeding
结局指标
主要结局
Development of any adverse events of Grade 3 or higher
时间窗: Throughout study
Development of adverse events of Grade 3 or higher attributed to the study vaccines
时间窗: Throughout study
Viral breakthrough to greater than 1,000 copies/ml
时间窗: During the first 24 weeks of study
次要结局
未报告次要终点