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临床试验/NCT00287677
NCT00287677已完成4 期

Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients

Germans Trias i Pujol Hospital2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
33
试验地点
2
主要终点
Proportion of patients HIV+ that recover the immunospecific responses against tetanus toxoid and Hepatitis A at 24 weeks of rhGH administration (time of treatment interruption).

研究概览

简要总结

Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion of immune reconstitution and broaden specific T cell responses not achievable by vaccination alone. The main objective of that study is to test the validity of this hypothesis with vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the near future. This is a pilot, randomized, clinical open label study aimed to investigate thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1 infected patients in highly active antiretroviral therapy (HAART) regimen.

详细描述

The purpose of a therapeutic vaccine is to control, induce and expand humoral and cellular immune responses capable to control HIV infection. The administration of a conventional vaccine results in the expansion of peripheral clones. Concomitant administration of rhGH may boost this expansion and reconstitute specific T cell responses not achievable by vaccination alone. In this study we want to investigate whether the administration of rhGH expand T cell repertoire and whether there is an increase in the specific cellular responses to HIV-1 and recall antigens and, lately, whether this responses can be further amplified after immunization with tetanus toxoid and hepatitis A vaccines. This Hypothesis will be evaluated by the measurement of thymic volume, the expansion of naïve, memory and effector cell subsets, analysis of thymic emigrants (TRECs) before, during and after rhGH administration and vaccination. Moreover, T cell receptor rearrangement, specific antibodies and cellular responses to antigenic peptides will be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-1 asymptomatic patients in HAART regimen (> 6 months)
  • Viral load < 50 copies/ml
  • Number CD4 cells > 250 cells/mm3
  • Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)
  • Well-disposition to rhGh daily administration (6 months of treatment)

排除标准

  • AIDS outbreak
  • Allergy or hyperreactivity to rhGH or vaccines
  • Diabetes Mellitus
  • Renal, hepatic, pancreatic disorders
  • Chronic diseases

研究组 & 干预措施

A

Experimental

growth hormone + vaccination + HAART

干预措施: recombinant human Growth Hormone (Biological)

A

Experimental

growth hormone + vaccination + HAART

干预措施: Vaccination (Biological)

A

Experimental

growth hormone + vaccination + HAART

干预措施: HAART (Drug)

B

Experimental

growth hormone + HAART

干预措施: recombinant human Growth Hormone (Biological)

B

Experimental

growth hormone + HAART

干预措施: HAART (Drug)

C

Experimental

vaccination + HAART

干预措施: Vaccination (Biological)

C

Experimental

vaccination + HAART

干预措施: HAART (Drug)

D

Active Comparator

control healthy HIV negative + vaccination

干预措施: Vaccination (Biological)

结局指标

主要结局

Proportion of patients HIV+ that recover the immunospecific responses against tetanus toxoid and Hepatitis A at 24 weeks of rhGH administration (time of treatment interruption).

时间窗: from 24 weeks post rhGH administration

次要结局

  • The rhGH activates the thymic function.(from one year post rhGH administration)
  • This effect is lasting once the rhGH administration is interrupted.(from at least one year since the last rhGH administration)

研究者

申办方类型
Other

研究点 (2)

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