CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,
CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,
批准号:
7603224
负责人:
JAMES M MARKERT
金额:
$1.16万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-03-01 至 2008-02-29
关键词:
ALVACAntigensAntiviral AgentsCD4 Positive T LymphocytesCell CountComputer Retrieval of Information on Scientific Projects DatabaseEnd PointFundingG207GrantHIV immunizationHIV-1ImmunizationInstitutionMalignant GliomaMethodsNumbersPhasePhase I Clinical TrialsPilot ProjectsPlacebosPlasmaRNARandomizedResearchResearch PersonnelResourcesSafetySourceStagingUnited States National Institutes of HealthUpper armVaccinesWeekWithdrawalantiretroviral therapy
中文摘要
这个子项目是众多研究子项目之一
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
A5068 is a randomized phase I/II pilot study intended to evaluate the safety, antiviral effects and immunological effects of intermittent withdrawal of potent antiretroviral therapy as an immunization strategy, ALVAC-HIV immunization, and the two strategies combined. The primary objectives are to
compare the effect of different methods of antigen stimulation (intermittent potent ART withdrawal versus ALVAC versus both) versus no antigen stimulation on the mean of the log10 HIV-1 RNA copies/mL in the last 2 weeks of the endpoint readout period (Step 6) of potent ART withdrawal, and to establish the safety of intermittent withdrawal of antiretroviral therapy with and without HIV-specific vaccine in subjects with persistent CD4+ T-cell counts >400/mm3 and persistent plasma HIV-1 RNA levels <50 copies/mL.
Subjects will be randomized in equal numbers (25 per arm) to one of four arms:
Arm A: Placebo immunization (ALVAC placebo) + potent ART for 92 weeks with one 12- to 20-week therapy withdrawal period.
Arm B: Placebo immunization (ALVAC placebo) + potent ART for 84 weeks with one 4- to 6-week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12- to 20-week therapy withdrawal period.
Arm C: Vaccine immunization (ALVAC vCP1452) + potent ART for 92 weeks with one 12- to 20-week therapy withdrawal period.
Arm D: Vaccine immunization (ALVAC vCP1452) + potent ART for 84 weeks with one 4- to 6-week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12- to 20-week therapy withdrawal period.
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资助金额:$18.01万
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财政年份:2009
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依托单位:
CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,
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批准号:7380481
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项目类别:
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资助金额:$0.71万
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财政年份:2006
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负责人:JAMES M MARKERT
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依托单位:
GENETICALLY ENGINEERED HSV 1 IN MALIGNANT GLIOMA
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批准号:6565381
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项目类别:
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资助金额:$17.53万
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财政年份:2001
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负责人:JAMES M MARKERT
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依托单位:
GENETICALLY ENGINEERED HSV 1 IN MALIGNANT GLIOMA
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批准号:6410697
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资助金额:$17.53万
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财政年份:2000
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GENETICALLY ENGINEERED HSV 1 IN MALIGNANT GLIOMA
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批准号:6302991
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资助金额:$2.95万
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财政年份:1999
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依托单位:
GENETICALLY ENGINEERED HSV 1 IN MALIGNANT GLIOMA
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批准号:6263442
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资助金额:$2.95万
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财政年份:1998
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ENGINEERED HERPES SIMPLEX VIRUS FOR TREATMENT OF GLIOMAS
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财政年份:1997
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依托单位:
ENGINEERED HERPES SIMPLEX VIRUS FOR TREATMENT OF GLIOMAS
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批准号:6393132
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资助金额:$12.52万
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财政年份:1997
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依托单位:
ENGINEERED HERPES SIMPLEX VIRUS FOR TREATMENT OF GLIOMAS
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资助金额:$7.88万
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财政年份:1997
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依托单位:
ENGINEERED HERPES SIMPLEX VIRUS FOR TREATMENT OF GLIOMAS
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资助金额:$8.96万
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财政年份:1997
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依托单位:
ENGINEERED HERPES SIMPLEX VIRUS FOR TREATMENT OF GLIOMAS
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批准号:2771879
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项目类别:
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资助金额:$8.96万
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财政年份:1997
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依托单位:
Lessons from the OR: Using Clinical Biologic Correlates to Inform HSV Trial
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资助金额:$16.29万
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财政年份:--
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依托单位:
Lessons from the OR: Using Clinical Biologic Correlates to Inform HSV Trial
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资助金额:$17.51万
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财政年份:--
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依托单位:
Lessons from the OR: Using Clinical Biologic Correlates to Inform HSV Trial
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批准号:8080207
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项目类别:
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资助金额:$18.07万
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财政年份:--
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负责人:JAMES M MARKERT
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