NCT02437526Enrolling By Invitation不适用
Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to virologic rebound
研究概览
简要总结
This study is designed to determine if individual patients with HIV infection have been cured of the infection. To do this, antiretroviral therapy is discontinued under close medical supervision and the patient monitored over time for reactivation of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age ≥ 18 years
- •HIV-1 infected with the potential to have been cured of infection in the course of routine clinical care in the opinion of the treating physician and study team
- •Have an undetectable plasma HIV-1 RNA and undetectable proviral DNA on suppressive antiretroviral therapy on at least two consecutive measures for at least 6 months
- •Able and willing to either abstain from sexual activity or use barrier contraceptives during the ATI
- •Negative serum β-HCG pregnancy test in women with childbearing potential
- •Have the ability to give appropriate informed consent.
排除标准
- •Women who are pregnant or nursing
- •Women who can become pregnant who are unable or unwilling to use both barrier and pharmacologic contraceptives during the ATI
- •Previous or current infections that are at high risk of reactivating with immune suppression, in whom there are no effective antimicrobial prophylaxis options
- •Advanced cardiopulmonary or liver disease
- •History of untreated solid or hematologic malignancies
- •Evidence of active viral replication in patients co-infected with Hepatitis B virus (HBV). Treatment should be provided to suppress HBV replication with agents that do not have activity against HIV (ie entecavir) prior to consideration for ATI.
- •Evidence of viral replication with Hepatitis C virus (HCV), together with evidence of any hepatic fibrosis or inflammation. Such patients should be offered HCV treatment first.
研究组 & 干预措施
Treatment interruption
Experimental
Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision.
干预措施: Analytic treatment interruption (Other)
结局指标
主要结局
Time to virologic rebound
时间窗: 38 weeks
次要结局
- Time to HIV-1 RNA ≥ 100 copies/ml(38 weeks)
- Time to HIV-1 RNA ≥ 20 copies/ml(38 weeks)
研究者
Andrew D. Badley, M.D.
Professor of Medicine
Mayo Clinic
研究点 (1)
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