Evaluation and Monitoring of Patients With HIV Infectionn
Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection
This study is designed to learn more about HIV infection and the conditions associated with it.
Patients 18 years of age or older with known or suspected HIV infection may be eligible for this study. Patients may have participated in previous NIH studies.
Participants will have periodic physical examinations and blood tests, including evaluations for responses to treatment. Treatment consistent with accepted standard medical practice will be individualized for each patient. Patients who previously participated in a NIH study will be followed for possible long-term benefits or side effects of treatment. Patients treated with alpha-interferon or interleukin-2 (IL-2) may continue treatment with that medication if it is felt that they might benefit from it. Blood samples may be drawn as part of standard medical care and for research purposes. Other tests may be done as appropriate for diagnosis and treatment, including, for example, a chest X-ray, electrocardiogram, or tissue biopsy. Patients will be seen for follow-up visits at regular intervals to monitor treatment progress.
Certain patients currently enrolled in a NIH study of IL-2 treatment may participate in a phase of the study that adds a corticosteroid, such as hydrocortisone, prednisone, or prednisonolone, to the regimen. Patients whose CD4 counts did not increase with IL-2 will receive corticosteroids (by mouth or by vein) in an open manner. Patients who responded to IL-2 therapy will be randomly assigned to receive corticosteroids or a placebo (inactive substance) during IL-2 infusions in a blinded manner, so that neither the patient nor the medical staff will know which patients are receiving the drug and which are receiving a placebo. Participants will be requested to receive at least three rounds of treatment with corticosteroid or placebo.
Patients currently taking IL-2 by subcutaneous injection (under the skin) may participate in an optional part of the study to receive future IL-2 cycles at home instead of at or near the Clinical Center. Patients who have shown an ability to self-administer and tolerate IL-2 injections with minimal supervision and minimal side effects may be eligible for this option. Home administration of IL-2 involves less frequent data and safety monitoring, and no on-site medical evaluation at the very beginning of each cycle. Participants will continue to be seen at the Clinical Center for regularly scheduled follow-up visits and medical evaluations before the start of each IL-2 cycle to determine if it is safe to begin that cycle. Patients will have a case manager who will place monitoring calls on days 2 and 4 of the cycle and a third follow-up call 1 week later. Patients will be responsible for contacting a study staff member if complications of other problems develop at other times.
研究概览
地位
条件
详细说明
研究类型
注册
联系人和位置
学习地点
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Maryland
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Bethesda、Maryland、美国、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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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:
HIV-infection, as documented by positive HIV ELISA and Western Blot. Patients may also be included if they have laboratory or clinical evidence suggestive of possible HIV-infection.
Age 18 years or older.
Ability to give written, informed consent.
CD4 cell count of any level.
Patients may be receiving anti-retroviral therapy, and any medications provided by their primary physician for the treatment of HIV and its complications.
Patients who lack primary medical care outside the NIH may be enrolled in this protocol.
学习计划
研究是如何设计的?
合作者和调查者
出版物和有用的链接
一般刊物
- Mahnke YD, Greenwald JH, DerSimonian R, Roby G, Antonelli LR, Sher A, Roederer M, Sereti I. Selective expansion of polyfunctional pathogen-specific CD4(+) T cells in HIV-1-infected patients with immune reconstitution inflammatory syndrome. Blood. 2012 Mar 29;119(13):3105-12. doi: 10.1182/blood-2011-09-380840. Epub 2012 Jan 4.
- Antonelli LR, Mahnke Y, Hodge JN, Porter BO, Barber DL, DerSimonian R, Greenwald JH, Roby G, Mican J, Sher A, Roederer M, Sereti I. Elevated frequencies of highly activated CD4+ T cells in HIV+ patients developing immune reconstitution inflammatory syndrome. Blood. 2010 Nov 11;116(19):3818-27. doi: 10.1182/blood-2010-05-285080. Epub 2010 Jul 26.
- Andrieu JM, Lu W, Levy R. Sustained increases in CD4 cell counts in asymptomatic human immunodeficiency virus type 1-seropositive patients treated with prednisolone for 1 year. J Infect Dis. 1995 Mar;171(3):523-30. doi: 10.1093/infdis/171.3.523.
- Kopp JB, Miller KD, Mican JA, Feuerstein IM, Vaughan E, Baker C, Pannell LK, Falloon J. Crystalluria and urinary tract abnormalities associated with indinavir. Ann Intern Med. 1997 Jul 15;127(2):119-25. doi: 10.7326/0003-4819-127-2-199707150-00004.
- Gea-Banacloche JC, Weiskopf EE, Hallahan C, Lopez Bernaldo de Quiros JC, Flanigan M, Mican JM, Falloon J, Baseler M, Stevens R, Lane HC, Connors M. Progression of human immunodeficiency virus disease is associated with increasing disruptions within the CD4+ T cell receptor repertoire. J Infect Dis. 1998 Mar;177(3):579-85. doi: 10.1086/514233.
研究记录日期
研究主要日期
学习开始
初级完成 (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 (实际的)
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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