ACTG366:PHASEI & II MASTER PROT OF NOVEL ANTIRETROVIRAL COMBINATION T
ACTG366:PHASEI & II MASTER PROT OF NOVEL ANTIRETROVIRAL COMBINATION T
批准号:
6264745
负责人:
William Thomas Shearer
金额:
$3.6万
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30
关键词:
2'3' dideoxycytidine 2'3' dideoxyinosine HIV infections antiAIDS agent child (0-11) clinical research clinical trial phase I combination chemotherapy drug adverse effect drug screening /evaluation human subject human therapy evaluation lamivudine nevirapine pediatric AIDS protease inhibitor ritonavir stavudine zidovudine
中文摘要
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英文摘要
This is a 52-week study of children with advanced HIV infection and their response to drug combinations, including zidovudine (AZT, ZDV), didanosine (ddI), zalcitabine (ddC), stavudine (d4T), lamivudine (3TC), nevirapine (Virarume), ritonavir (Norvir), and nelfinavir (Viracept). All drugs except nevirapine and ddC have been FDA approved for use in children. Two hundred children will participate nationwide and 8 children locally. Drugs are taken for 52 weeks, and if tolerated, patients are offered an option for an additional 48 weeks of therapy. Study endpoints include: a) lack of viral load suppression (RNA PCR), i.e., < 0.75, b) treatment safety, and c) performance of pharmacokinetics (PK) of study drug combinations. Secondary endpoints include study of specific characteristics of HIV RNA changes (slope, nadir, AUC, etc.), CD4 change, weight change, population PK and survival comparisons.
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科研奖励(0)
会议论文
PACTG P1026S (VERSION 20), PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUG
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批准号:8356662
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项目类别:
-
资助金额:$4.13万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
A5240 (VERSION 10) A PHASE II STUDY TO EVALUATE THE IMMUNOGENICITY AND SAFETY
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批准号:8356728
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项目类别:
-
资助金额:$2.64万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
IMPAACT 1077HS (VS 10) HAART STANDARD VERSION OF THE PROMISE STUDY
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批准号:8356740
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项目类别:
-
资助金额:$0.79万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
Baylor College of Medicine Clinical Trial Unit
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批准号:8138733
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项目类别:
-
资助金额:$15.35万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
PHACS PH 100 SURVEILLANCE MONITORING FOR ART TOXICITIES STUDY IN HIV-UNINFEC
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批准号:8356681
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项目类别:
-
资助金额:$10.38万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: IMPAACT P1086 (VS 10) A PHASE II STUDY TO ASSESS THE SAFETY AN
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批准号:8356734
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项目类别:
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资助金额:$1.5万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
PH 201 MEMORY FUNCTIONING IN CHILDREN AND ADOLESCENTS WITH PERINATAL HIV
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批准号:8356748
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项目类别:
-
资助金额:$1.5万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: IMPAACT P1088 (VERSION 10) A PHASE II STUDY TO ASSESS THE SAFET
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批准号:8356737
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项目类别:
-
资助金额:$1.14万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: IMPAACT P1066 (VERSION 10) A PHASE I/II, MULTICENTER, OPEN-LAB
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批准号:8356688
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项目类别:
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资助金额:$0.7万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
DURATION OF HUMAN PAPILLOMA VIRUS (HPV) TYPE-SPECIFIC ANTIBODY
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批准号:8356754
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项目类别:
-
资助金额:$0.26万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
H-19197 PHACS PH 200 ADOLESCENT MASTER PROTOCOL (AMP)
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批准号:8356682
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项目类别:
-
资助金额:$8.18万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: P1025 PERINATAL CORE PROTOCOL VERSION 10
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批准号:8356654
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项目类别:
-
资助金额:$11.17万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
A5241 (VERSION 10) THE OPTIMIZED TREATMENT THAT INCLUDES OR OMITS NRTIS
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批准号:8356712
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项目类别:
-
资助金额:$0.53万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: IMPAACT 1065 PHASE I/II STUDY OF SAFETY AND IMMUNOGENICITY OF Q
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批准号:8356683
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项目类别:
-
资助金额:$0.18万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
IMPAACT P1089 (VERSION 10) A LABORATORY STUDY TO ASSESS THE IMMUNOGENICITY
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批准号:8356738
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项目类别:
-
资助金额:$0.18万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
Clinical Research Core
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批准号:7930006
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项目类别:
-
资助金额:$24.01万
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财政年份:2010
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负责人:William Thomas Shearer
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依托单位:
PHACS PH 100 SURVEILLANCE MONITORING FOR ART TOXICITIES STUDY IN HIV-UNINFEC
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批准号:8166692
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项目类别:
-
资助金额:$9.72万
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财政年份:2009
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: IMPAACT 1065 PHASE I/II STUDY OF SAFETY AND IMMUNOGENICITY OF QU
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批准号:8166695
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项目类别:
-
资助金额:$1.48万
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财政年份:2009
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: PACTG 390-COMBINATION ANTIRETROVIRAL REGIMENS IN ANTIRETROVIRAL
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批准号:8166651
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项目类别:
-
资助金额:$0.58万
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财政年份:2009
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负责人:William Thomas Shearer
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依托单位:
CLINICAL TRIAL: IMPAACT P1086 (VS 10) A PHASE II STUDY TO ASSESS THE SAFETY AN
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批准号:8166748
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项目类别:
-
资助金额:$1.24万
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财政年份:2009
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负责人:William Thomas Shearer
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依托单位:
海外基金