Evaluating Immune Function Tests in People With HIV
HIV Antigen-Specific Immune Responses - A Comparison of Alternative In Vitro Assays From Subjects Characterized as Either "Stable HAART" or "Efficient Immune Control"
研究概览
地位
条件
详细说明
The efficiency of the immune response to HIV antigens is the critical feature that allows some individuals with chronic HIV infection to maintain low level viremia (less than 3000 copies/ml). The fundamental measurement of this response is the steady state level of viremia in the absence of antiretroviral drugs. However, using this clinical endpoint in vaccine and drug trials is time-consuming. Several laboratory assays of HIV T cell function have been developed to measure the key characteristics of an efficient immune response. This study will evaluate these assays in two distinct patient populations.
Two patient cohorts will be followed in this study. Cohort A will enroll patients who are stable on highly active antiretroviral therapy (HAART). These patients will have been on the same HAART regimen for at least 9 months prior to study entry. Cohort B will enroll patients with chronic HIV infection and efficient immune control. These patients will have not been on any antiretroviral drugs for at least 6 months and will have viral loads less than 3,000 copies/ml. Participants in both cohorts will have blood drawn at study entry and Weeks 12 and 24. Blood samples will be used for CD4/CD8 cell count, plasma HIV-1 RNA, and immunologic assays.
研究类型
注册
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35924-2050
- University of Alabama at Birmingham
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California
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Sacremento、California、美国、95814
- UC Davis Medical Center
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Florida
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Miami、Florida、美国、33136-1013
- University of Miami
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Illinois
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Chicago、Illinois、美国、60612-3806
- Rush-Presbyterian/St. Lukes
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Ohio
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Cleveland、Ohio、美国、44106-5083
- Case Western Reserve University
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213-2582
- University of Pittsburgh
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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 for Cohorts A and B:
- HIV-1 infection
- CD4 cell count > 300 cells/mm3 within 60 days prior to study entry
- Negative pregnancy test within 14 days of starting study
- Agree to use acceptable methods of contraception while in study
Inclusion Criteria for Cohort A (Stable HAART) Only:
- Stable HAART regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry
- Viral load < 75 copies/ml on at least three occasions within 9 months prior to study entry, with at least one of these values obtained between 6 and 9 months prior to study entry
- No single viral load >= 75 copies/ml within 9 months prior to study entry
Inclusion Criteria for Cohort B (Efficient Immune Control) Only:
- Not taking any antiretroviral drugs for at least 6 months prior to study entry
- Meets study definition of efficient immune control (generally HIV-1 viral load < 3,000 copies/ml, with some exceptions)
Exclusion Criteria:
- Pregnancy or breast-feeding
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- History of an AIDS-defining opportunistic infection
学习计划
研究是如何设计的?
设计细节
合作者和调查者
调查人员
- 学习椅:R. Pat Bucy, MD, PhD、University of Alabama at Birmingham
出版物和有用的链接
一般刊物
- Bucy RP, Kilby JM. Perspectives on inducing efficient immune control of HIV-1 replication--a new goal for HIV therapeutics? AIDS. 2001 Feb;15 Suppl 2:S36-42. doi: 10.1097/00002030-200102002-00007.
- Bucy RP. Immune clearance of HIV type 1 replication-active cells: a model of two patterns of steady state HIV infection. AIDS Res Hum Retroviruses. 1999 Feb 10;15(3):223-7. doi: 10.1089/088922299311394. No abstract available.
- Pantaleo G, Menzo S, Vaccarezza M, Graziosi C, Cohen OJ, Demarest JF, Montefiori D, Orenstein JM, Fox C, Schrager LK, et al. Studies in subjects with long-term nonprogressive human immunodeficiency virus infection. N Engl J Med. 1995 Jan 26;332(4):209-16. doi: 10.1056/NEJM199501263320402.
- Macatangay BJ, Zheng L, Rinaldo CR, Landay AL, Pollard RB, Pahwa S, Lederman MM, Bucy RP. Comparison of immunologic assays for detecting immune responses in HIV immunotherapeutic studies: AIDS Clinical Trials Group Trial A5181. Clin Vaccine Immunol. 2010 Sep;17(9):1452-9. doi: 10.1128/CVI.00498-09. Epub 2010 Jul 14.
研究记录日期
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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