Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy
研究概览
详细说明
Step I: In addition to continuing HAART, patients are randomized into 1 of the following 4 arms:
A: Immunization placebo; B: Immunization with the canarypox HIV-vaccine (vCP1452); C: Daily low-dose IL-2 + immunization placebo; or D: Daily low-dose IL-2 + canarypox HIV-vaccine (vCP1452). Patients on Arms A, B, C, and D receive vaccine (or vaccine placebo) injections at Weeks 0, 4, 8, and 12. Patients on Arms C and D receive IL-2 by self-injection. HAART is not provided as part of this study.
Step II: Patients on all arms (A, B, C, and D) who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks. The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy. After 12 weeks of Step II, patients whose viral load remains below 30,000 copies/ml remain on Step II, off HAART, and continue weekly viral load monitoring. Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30,000 copies/ml on 3 successive determinations, or their CD4 count decreases to less than 200 cells/mm3 or less than 50 percent of the baseline CD4+ T cell concentration on 2 successive occasions.
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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New York
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New York、New York、美国、10021
- New York Hosp - Cornell Med Ctr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Are more than 18 years old.
- Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months.
- Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have not had virologic failure on the current HAART regimen.
- Have a negative urine pregnancy test within 14 days of entering the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a current AIDS-defining illness.
- Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml).
- Have a history of using agents affecting the immune system.
- Have active uncontrolled heart disease.
- Have had IL-2 therapy within 4 weeks of entering the study.
- Have received other treatment that affects the immune system within 4 weeks of entry.
- Have a history of a cancer requiring chemotherapy.
- Have untreated thyroid disease, within 4 weeks of entering the study.
- Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis.
- Abuse substances that may interfere with the ability to follow study requirements.
- Are allergic to eggs.
- Have hepatitis B or hepatitis C.
- Are pregnant or breast-feeding.
- Work in close contact with canaries, such as a job at breeding farms or bird shops.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption
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次要结果测量
结果测量 |
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Proportion of participants who relapse during the first 12 weeks following stopping of HAART
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length of time to the termination of Step II among participants
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changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II
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合作者和调查者
调查人员
- 首席研究员:Kendall A. Smith, MD、Division of Immunology, Department of Medicine, Weill Medical College, Cornell University
研究记录日期
研究主要日期
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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