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五种高致死(残)性艾滋病机会性感染及难治性艾滋病的精准诊治策略研究
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注册号:

Registration number:

ChiCTR1900021195 

最近更新日期:

Date of Last Refreshed on:

2019-02-01 

注册时间:

Date of Registration:

2019-02-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

五种高致死(残)性艾滋病机会性感染及难治性艾滋病的精准诊治策略研究 

Public title:

A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

五种高致死(残)性艾滋病机会性感染及难治性艾滋病的精准诊治策略研究 

Scientific title:

A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

鲁雁秋 

研究负责人:

陈耀凯 

Applicant:

Yanqiu Lu 

Study leader:

Yaokai Chen 

申请注册联系人电话:

Applicant telephone:

+86 13657686269 

研究负责人电话:

Study leader's telephone:

+86 13838352995 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

doctorlu829@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yaokaichen@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

重庆市沙坪坝区歌乐山镇保育路109号 

研究负责人通讯地址:

重庆市沙坪坝区歌乐山镇保育路109号 

Applicant address:

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, China 

Study leader's address:

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

重庆市公共卫生医疗救治中心 

Applicant's institution:

Chongqing Public Health Medical Center  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019-003-02-KY 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

重庆市公共卫生医疗救治中心伦理委员会 

Name of the ethic committee:

The Ethic Committee of Chongqing Public Health Medical Center  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-29 

伦理委员会联系人:

陈亚玲 

Contact Name of the ethic committee:

Yaling Chen 

伦理委员会联系地址:

重庆市沙坪坝区歌乐山镇保育路109号 

Contact Address of the ethic committee:

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

重庆市公共卫生医疗救治中心 

Primary sponsor:

Chongqing Public health medical center 

研究实施负责(组长)单位地址:

重庆市沙坪坝区歌乐山镇保育路109号 

Primary sponsor's address:

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市公共卫生医疗救治中心

具体地址:

重庆市沙坪坝区歌乐山镇保育路109号

Institution
hospital:

Chongqing Public health medical center

Address:

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, China

经费或物资来源:

“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项 

Source(s) of funding:

National Science and Technology Major Project -  

研究疾病:

艾滋病机会性感染及难治性艾滋病 

Target disease:

AIDS opportunistic infections and refractory AIDS 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

在大样本回顾性病例研究和前瞻性队列基础上,系统性开展隐球菌性脑膜炎等五种我国高发病率高致死(残)性艾滋病机会性感染分型分期诊断研究;并通过开展规范的大样本前瞻性队列研究,研究该五种机会性感染诊断治疗新方案。 

Objectives of Study:

On the basis of large-scale retrospective case study and prospective cohort, systematically conducted five kinds of high-incidence and high-risk AIDS opportunistic infections in China, such as cryptococcal meningitis, and through the standardized study. A large sample prospective cohort study to study the new five diagnostic options for opportunistic infections. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

一、隐球菌抗原筛查及早期干预对艾滋病患者隐球菌性脑膜炎发病率影响的多中心前瞻性随机对照研究 (1)年龄 ≥18 岁; (2)ELISA检测HIV-1抗体阳性并通过Western Blot 法确认; (3)临床诊断为隐球菌抗原血症; (4)CD4+T淋巴细胞计数<200个/μl; (5)自愿签署受试者知情同意书,并愿意接受随访; (6)研究者认为,受试者总体状况不影响试验的评估和完成。 二、艾滋病合并隐球菌性脑膜炎患者颅内压管理策略的多中心前瞻性队列研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为隐球菌性脑膜炎; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成; (6)任一次腰椎穿刺检查提示脑压≥250 mmH2O 者。 三、不同抗真菌方案对艾滋病合并隐球菌性脑膜炎患者疗效和安全性的多中心前瞻性随机对照研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为隐球菌性脑膜炎; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成。 四、艾滋病合并隐球菌脑膜炎患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为隐球菌性脑膜炎; (4)既往未接受过任何抗逆转录病毒治疗; (5)自愿签署受试者知情同意书,并愿意接受随访; (6)研究者认为,受试者总体状况不影响试验的评估和完成。 五、抗弓形虫方案治疗艾滋病合并弓形虫脑病患者疗效与安全性的多中心前瞻性随机对照研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为弓形虫脑病; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成。 六、艾滋病合并弓形虫脑病患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)年龄18-65岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为弓形虫脑病; (4)既往未接受过任何抗逆转录病毒治疗; (5)自愿签署受试者知情同意书,并愿意接受随访; (6)研究者认为,受试者总体状况不影响试验的评估和完成。 七、抗肺孢子菌新方案治疗艾滋病合并中重度肺孢子菌肺炎患者疗效与安全性的多中心前瞻性队列研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为中重度PCP; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成。 八、艾滋病合并肺孢子菌肺炎患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为中重度PCP; (4)既往未接受过任何抗逆转录病毒治疗; (5)自愿签署受试者知情同意书,并愿意接受随访; (6)研究者认为,受试者总体状况不影响试验的评估和完成。 九、抗巨细胞病毒新方案治疗艾滋病合并巨细胞病毒性视网膜炎患者疗效与安全性的多中心前瞻性队列研究 (1)年龄18-65岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为CMVR; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成。 十、艾滋病合并巨细胞病毒性视网膜炎抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)年龄18-65岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为CMVR; (4)既往未接受过任何抗逆转录病毒治疗; (5)自愿签署受试者知情同意书,并愿意接受随访; (6)研究者认为,受试者总体状况不影响试验的评估和完成。 十一、不同抗真菌方案治疗艾滋病合并马尔尼菲篮状菌病患者疗效和安全性的多中心前瞻性随机对照研究 (1)年龄18-65岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为马尔尼菲篮状菌病; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成。 十二、艾滋病合并马尔尼菲篮状菌病患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)年龄18-65 岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断为马尔尼菲篮状菌病; (4)既往未接受过任何抗逆转录病毒治疗; (5)自愿签署受试者知情同意书,并愿意接受随访; (6)研究者认为,受试者总体状况不影响试验的评估和完成。 十三、HIV合并肺孢子菌感染核酸检测技术及临床验证研究 (1)年龄18-65 岁; (2)临床诊断为健康、HIV 感染、HIV 合并PCP 感染(轻、中重度); (3)自愿签署受试者知情同意书,并愿意接受随访; (4)研究者认为,受试者总体状况不影响试验的评估和完成。 十四、HIV合并弓形虫感染核酸检测技术及临床验证研究 (1)年龄18-65岁; (2)临床诊断为健康、HIV 感染、HIV 合并弓形虫感染; (3)自愿签署受试者知情同意书,并愿意接受随访; (4)研究者认为,受试者总体状况不影响试验的评估和完成。 十五、五种艾滋病机会性感染分型分期的回顾性队列研究 (1)年龄≥18岁; (2)ELISA 检测HIV-1 抗体阳性并通过Western Blot 法确认; (3)临床诊断有隐球菌性脑膜炎/弓形虫脑病/巨细胞病毒性视网膜炎/肺孢子菌肺炎/马尔尼菲篮状菌病。 

Inclusion criteria

1. Impact of cryptococcal antigen screening and antifungal interventions on incidence of cryptococcal meningitis in HIV-infected patients: a multicenter prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcus antigenemia was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 2. Management strategies of high intracranial pressures in HIV-infected patients with cryptococcal meningitis: a multicenter prospective cohort study (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment; (6) Any lumbar puncture showed that the cerebral pressure≥ 250 mmH2O. 3. Efficiency and safety of antifungal regimens in HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 4. Timing of antiretroviral therapy for HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 5. Efficiency and safety of anti-toxoplasma regimens in HIV-infected patients with toxoplasma encephalopathy: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Toxoplasma gondii Encephalitis was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 6. Timing of antiretroviral therapy for HIV-infected patients with toxoplasmic encephalitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Toxoplasma gondii Encephalitis was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 7. Efficiency and safety of anti-pneumocystis regimens in HIV-infected patients with moderate-to-severe pneumocystis pneumonia: a multi-center prospective cohort study (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Moderate to severe PCP was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 8. Timing of antiretroviral therapy for HIV-infected patients with pneumocystis pneumonia: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Moderate to severe PCP was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 9. Efficiency and safety of anti-cytomegalovirus regimens in HIV-infected patients with cytomegalovirus retinitis: a multi-center prospective cohort study (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) CMVR was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 10. Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) CMVR was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 11. Efficiency and safety of antifungal therapy in HIV-infected patients with penicilliposis marneffei: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Penicilliposis marneffei was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 12. Timing of antiretroviral therapy for HIV-infected patients with penicilliposis marneffei: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Penicilliposis marneffei was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 13. Nucleic acid testing and clinical verification in HIV-infected patients with Pneumocystis infection (1) 18-65 years old; (2) Healthy people, HIV infectors or HIV infectors with PCP; (3) Voluntary signature of informed consent and willingness to be followed up; (4) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 14. Nucleic acid testing and clinical verification in HIV-infected patients with HIV-infected patients with Toxoplasma gondii infection (1) 18-65 years old; (2) Healthy people, HIV infectors or HIV infectors with Toxoplasma encephalopathy infection; (3) Voluntary signature of informed consent and willingness to be followed up; (4) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 15.Staging and typing strategies of opportunistic infections in populations with acquired immunodeficiency syndrome: a retrospective cohort study (1) ≥18 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis/ toxoplasmic encephalitis/ cytomegalovirus retinitis/ PCP /penicilliposis marneffei/ was clinically diagnosed. 

排除标准:

一、 隐球菌抗原筛查及早期干预对艾滋病患者隐球菌性脑膜炎发病率影响的多中心前瞻性随机对照研究 (1)对氟康唑严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)既往确诊过或目前确诊为隐球菌性脑膜炎患者; (4)正在规范使用抗真菌药物者; (5)合并其他疾病影响疗效及预后者; (6)合并其他机会性感染且病情不稳定者; (7)有严重心、脑、肺、肾、肿瘤等基础疾病; (8)妊娠期、哺乳期的妇女; (9)有严重精神性疾病的患者; (10)静脉吸毒者; (11)非中国国籍人员。 二、艾滋病合并隐球菌性脑膜炎患者颅内压管理策略的多中心前瞻性队列研究 (1)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (2)合并其他疾病影响疗效及预后者; (3)合并其他机会性感染且病情不稳定者; (4)有严重心、脑、肺、肾、肿瘤等基础疾病; (5)妊娠期、哺乳期的妇女; (6)有严重精神性疾病的患者; (7)静脉吸毒者; (8)非中国国籍人员。 三、不同抗真菌方案对艾滋病合并隐球菌性脑膜炎患者疗效和安全性的多中心前瞻性随机对照研究 (1)对两性霉素B脱氧胆酸盐、氟康唑、伏立康唑、氟胞嘧啶等治疗药物严重过敏或不能耐受者; (2)既往确诊过隐球菌性脑膜炎且近1月有接受过规范隐球菌治疗者; (3)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (4)合并其他疾病影响疗效及预后者; (5)合并其他机会性感染且病情不稳定者; (6)有严重心、脑、肺、肾、肿瘤等基础疾病; (7)妊娠期、哺乳期的妇女; (8)有严重精神性疾病的患者; (9)静脉吸毒者; (10)非中国国籍人员。 四、艾滋病合并隐球菌脑膜炎患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)对相关治疗药物严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)合并其他疾病影响疗效及预后者; (4)合并其他机会性感染且病情不稳定者; (5)有严重心、脑、肺、肾、肿瘤等基础疾病; (6)妊娠期、哺乳期的妇女; (7)有严重精神性疾病的患者; (8)静脉吸毒者; (9)非中国国籍人员。 五、抗弓形虫方案治疗艾滋病合并弓形虫脑病患者疗效与安全性的多中心前瞻性随机对照研究 (1)对相关治疗药物严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)合并其他疾病影响疗效及预后者; (4)合并其他机会性感染且病情不稳定者; (5)有严重心、脑、肺、肾、肿瘤等基础疾病; (6)妊娠期、哺乳期的妇女; (7)有严重精神性疾病的患者; (8)静脉吸毒者; (9)非中国国籍人员。 六、艾滋病合并弓形虫脑病患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)对相关治疗药物严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)合并其他疾病影响疗效及预后者; (4)合并其他机会性感染且病情不稳定者; (5)有严重心、脑、肺、肾、肿瘤等基础疾病; (6)妊娠期、哺乳期的妇女; (7)有严重精神性疾病的患者; (8)静脉吸毒者; (9)非中国国籍人员。 七、抗肺孢子菌新方案治疗艾滋病合并中重度肺孢子菌肺炎患者疗效与安全性的多中心前瞻性队列研究轻度PCP患者; (2)对相关治疗药物严重过敏或不能耐受者; (3)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血肌酐>1.5倍参考水平上限、血淀粉酶>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (4)合并其他疾病影响疗效及预后者; (5)合并其他机会性感染且病情不稳定者; (6)有严重心、脑、肺、肾、肿瘤等基础疾病; (7)妊娠期、哺乳期的妇女; (8)有严重精神性疾病的受试者; (9)静脉吸毒者; (10)非中国国籍人员。 八、艾滋病合并肺孢子菌肺炎患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)轻度PCP患者; (2)对相关治疗药物严重过敏或不能耐受者; (3)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血肌酐>1.5倍参考水平上限、血淀粉酶>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (4)合并其他疾病影响疗效及预后者; (5)合并其他机会性感染且病情不稳定者; (6)有严重心、脑、肺、肾、肿瘤等基础疾病; (7)妊娠期、哺乳期的妇女; (8)有严重精神性疾病的患者; (9)静脉吸毒者; (10)非中国国籍人员。 九、抗巨细胞病毒新方案治疗艾滋病合并巨细胞病毒性视网膜炎患者疗效与安全性的多中心前瞻性队列研究 (1)对膦甲酸钠、地塞米松或更昔洛韦严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍正常水平上限、血肌酐>1.5倍正常水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍正常水平上限、总胆红素>2倍正常水平上限、血清肌酸磷酸肌酶(CK)>2倍正常水平上限; (3)入组时前一个月内接受过规范CMVR治疗; (4)合并其他疾病影响疗效及预后者; (5)合并其他机会性感染且病情不稳定者; (6)有严重心、脑、肺、肾、肿瘤等基础疾病; (7)妊娠期、哺乳期的妇女; (8)有严重精神性疾病的患者; (9)静脉吸毒者; (10)非中国国籍人员。 十、艾滋病合并巨细胞病毒性视网膜炎抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)对膦甲酸钠、地塞米松或更昔洛韦等治疗药物严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)入组时前一个月内接受过规范CMVR治疗; (4)合并其他疾病影响疗效及预后者; (5)合并其他机会性感染且病情不稳定者; (6)有严重心、脑、肺、肾、肿瘤等基础疾病; (7)妊娠期、哺乳期的妇女; (8)有严重精神性疾病的患者; (9)静脉吸毒者; (10)非中国国籍人员。 十一、不同抗真菌方案治疗艾滋病合并马尔尼菲篮状菌病患者疗效和安全性的多中心前瞻性随机对照研究 (1)对两性霉素B脱氧胆酸盐、伏立康唑或伊曲康唑等药物严重过敏或者不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)在入组时前一个月内接受过全身性抗真菌药物治疗,例如:两性霉素B脱氧胆酸盐、氟胞嘧啶、酮康唑、氟康唑、伊曲康唑、伏立康唑等; (4)合并其他疾病影响疗效及预后者; (5)合并其他机会性感染且病情不稳定者; (6)有严重心、脑、肺、肾、肿瘤等基础疾病; (7)妊娠期、哺乳期的妇女; (8)有严重精神性疾病的患者; (9)静脉吸毒者; (10)非中国国籍人员。 十二、艾滋病合并马尔尼菲篮状菌病患者抗反转录病毒治疗启动时机的多中心前瞻性随机对照研究 (1)对两性霉素B脱氧胆酸盐、伏立康唑或伊曲康唑等药物严重过敏或者不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×10^9 /L、中性粒细胞数<0.5×10^9 /L、血小板计数<50×10^9 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)合并其他疾病影响疗效及预后者; (4)合并其他感染性疾病影响疗效及预后者; (5)有严重心、脑、肺、肾、肿瘤等基础疾病; (6)妊娠期、哺乳期的妇女; (7)有严重精神性疾病的患者; (8)静脉吸毒者; (9)非中国国籍人员。 十三、HIV合并肺孢子菌感染核酸技术及临床验证研究 本研究仅在患者入院或住院期间收集患者血清和肺灌洗液,因此无排除标准。 十四、HIV合并弓形虫感染核酸技术及临床验证研究 本研究仅在患者入院或住院期间收集患者血清和脑脊液,因此无排除标准。 十五、五种艾滋病机会性感染分型分期的回顾性队列研究 本研究仅回顾性收集患者病历资料,因此无排除标准。 

Exclusion criteria:

1. Impact of cryptococcal antigen screening and antifungal interventions on incidence of cryptococcal meningitis in HIV-infected patients: a multicenter prospective randomized controlled trial (1) Seriously allergic or intolerant to fluconazole; (2) Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase>2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Patients who have been diagnosed or are currently diagnosed with cryptococcal meningitis; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 2. Management strategies of high intracranial pressures in HIV-infected patients with cryptococcal meningitis: a multicenter prospective cohort study (1) Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9 /L, blood amylase>2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (2) Combined with other diseases affecting efficacy and prognosis; (3) Concomitant other opportunistic infections and unstable conditions; (4) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (5) Women during pregnancy and lactation; (6) Patients with severe mental illness; (7) Intravenous drug addict; (8) Non-Chinese nationals. 3. Efficiency and safety of antifungal regimens in HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) Seriously allergic or intolerant to amphotericin B deoxycholate, fluconazole, voriconazole, flucytosine, etc.; (2) Patient has previously been diagnosed with cryptococcal meningitis and has been treated with normative cryptococcosis in the past month; (3) Hemoglobin <60g/L, white blood cell count <1.0×1^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9 /L, blood amylase>2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 4. Timing of antiretroviral therapy for HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) Severe allergy or intolerance to related therapeutic drugs; Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase>2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (2) Patients are regulating the use of antifungal drugs; (3) Combined with other diseases affecting efficacy and prognosis; (4) Concomitant other opportunistic infections and unstable conditions; (5) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (6) Women during pregnancy and lactation; (7) Patients with severe mental illness; (8) Intravenous drug addict; (9) Non-Chinese nationals. 5. Efficiency and safety of anti-toxoplasma regimens in HIV-infected patients with toxoplasma encephalopathy: a multi-center prospective randomized controlled trial (1) Severe allergy or intolerance to related therapeutic drugs; Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase>2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (2) Patients are regulating the use of antifungal drugs; (3) Combined with other diseases affecting efficacy and prognosis; (4) Concomitant other opportunistic infections and unstable conditions; (5) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (6) Women during pregnancy and lactation; (7) Patients with severe mental illness; (8) Intravenous drug addict; (9) Non-Chinese nationals. 6. Timing of antiretroviral therapy for HIV-infected patients with toxoplasmic encephalitis: a multi-center prospective randomized controlled trial (1) Severe allergy or intolerance to related therapeutic drugs; Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase>2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (2) Patients are regulating the use of antifungal drugs; (3) Combined with other diseases affecting efficacy and prognosis; (4) Concomitant other opportunistic infections and unstable conditions; (5) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (6) Women during pregnancy and lactation; (7) Patients with severe mental illness; (8) Intravenous drug addict; (9) Non-Chinese nationals. 7. Efficiency and safety of anti-pneumocystis regimens in HIV-infected patients with moderate-to-severe pneumocystis pneumonia: a multi-center prospective cohort study (1) Mild PCP patients; (2) Severe allergy or intolerance to related therapeutic drugs; Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase >2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Patients are regulating the use of antifungal drugs; (4) Combined with other diseases affecting efficacy and prognosis; (5) Concomitant other opportunistic infections and unstable conditions; (6) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (7) Women during pregnancy and lactation; (8) Patients with severe mental illness; (9) Intravenous drug addict; (10) Non-Chinese nationals. 8. Timing of antiretroviral therapy for HIV-infected patients with pneumocystis pneumonia: a multi-center prospective randomized controlled trial (1) Mild PCP patients; (2) Severe allergy or intolerance to related therapeutic drugs; (3) Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase>2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 9. Efficiency and safety of anti-cytomegalovirus regimens in HIV-infected patients with cytomegalovirus retinitis: a multi-center prospective cohort study (1) Severe allergy or intolerance to sodium foscarnet, dexamethasone or dexamethasone; (2) Hemoglobin <60g/L, white blood cell count <1.0×10^9 /L, neutrophil count <0.5×10^9 /L, platelet count <50×10^9 /L, blood amylase>2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Received standardized CMVR treatment within the previous month; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 10. Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: a multi-center prospective randomized controlled trial (1) Severe allergy or intolerance to sodium foscarnet, dexamethasone or dexamethasone; (2) Hemoglobin <60g/L, white blood cell count <1.0×10^9 /L, neutrophil count <0.5×10^9 /L, platelet count <50×10^9 /L, blood amylase >2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Received standardized CMVR treatment within the previous month; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 11. Efficiency and safety of antifungal therapy in HIV-infected patients with penicilliposis marneffei: a multi-center prospective randomized controlled trial (1) Seriously allergic or intolerant to drugs such as amphotericin B deoxycholate, voriconazole or itraconazole; (2) Hemoglobin <60g/L, white blood cell count <1.0×10^9 /L, neutrophil count <0.5×10^9 /L, platelet count <50×10^9 /L, blood amylase>2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Received systemic antifungal therapy within the first month of enrollment, for example: amphotericin B deoxycholate, flucytosine, ketoconazole, fluconazole, itraconazole, voriconazole, etc.; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 12. Timing of antiretroviral therapy for HIV-infected patients with penicilliposis marneffei: a multi-center prospective randomized controlled trial (1) Seriously allergic or intolerant to drugs such as amphotericin B deoxycholate, voriconazole or itraconazole; (2) Hemoglobin <60g/L, white blood cell count <1.0×10^9/L, neutrophil count <0.5×10^9/L, platelet count <50×10^9/L, blood amylase>2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Combined with other diseases affecting efficacy and prognosis; (4) Concomitant other opportunistic infections and unstable conditions; (5) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (6) Women during pregnancy and lactation; (7) Patients with severe mental illness; (8) Intravenous drug addict; (9) Non-Chinese nationals; 13. Nucleic acid testing and clinical verification in HIV-infected patients with Pneumocystis infection. 14. Nucleic acid testing and clinical verification in HIV-infected patients with HIV-infected patients with Toxoplasma gondii infection. 15. Staging and typing strategies of opportunistic infections in populations with acquired immunodeficiency syndrome: a retrospective cohort study. 

研究实施时间:

Study execute time:

From2019-02-11To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2019-02-11To 2020-12-31 

干预措施:

Interventions:

组别:

任务一,对照组

样本量:

150

Group:

Task 1, Control group

Sample size:

干预措施:

不采取干预措施。

干预措施代码:

Intervention:

No intervention is taken.

Intervention code:

组别:

任务一,干预组1

样本量:

150

Group:

Task 1, Intervention group 1

Sample size:

干预措施:

诱导期:氟康唑800mg/日,口服,2周;巩固期:氟康唑400mg/日,口服,8周;维持期:氟康唑200mg/日,口服,1年

干预措施代码:

Intervention:

Induction therapy: fluconazole 800mg/d, PO, for 2 weeks; consolidation therapy: fluconazole 400mg/d, PO, for 8 weeks; maintenance therapy: fluconazole 200mg/day, PO, for 1 year.

Intervention code:

组别:

任务一,干预组2

样本量:

150

Group:

Task 1, Intervention group 2

Sample size:

干预措施:

氟康唑400mg/日,口服,疗程1年

干预措施代码:

Intervention:

Fluconazole 400mg / day, PO, for 1 year.

Intervention code:

组别:

任务二,对照组

样本量:

100

Group:

Task 2, Control group

Sample size:

干预措施:

当受试者初始颅内压≥250mmH2O,根据其意愿,按照常规管理模式,对受试者进行不定期腰椎穿刺检查并释放脑脊液。

干预措施代码:

Intervention:

When the initial intracranial pressure≥250mmH2O, according to the patients' will, lumbar puncture and removing CSF should be done by regular.

Intervention code:

组别:

任务二,治疗性腰穿组

样本量:

100

Group:

Task 2, Therapeutic lumbar puncture group

Sample size:

干预措施:

当受试者初始颅内压≥250mmH2O,每日给予腰椎穿刺释放脑脊液以降低颅内压;每放10ml脑脊液,测量一次颅内压,直到受试者颅内压<初始颅内压的50%或压力<200mmH2O;当颅内压<200mmH2O达2天或2天以上时,可停止治疗性腰穿。

干预措施代码:

Intervention:

When the initial intracranial pressure is ≥ 250 mmH2O, lumbar puncture was given daily to reduce intracranial pressure. The intracranial pressure was measured once every 10ml of released cerebrospinal fluid, until the initial intracranial pressure< 50% of the initial intracranial pressure or the pressure< 200 mmH2

Intervention code:

组别:

任务二,引流组

样本量:

100

Group:

Task 2, Drainage group

Sample size:

干预措施:

当受试者初始颅内压≥250mmH2O,给予引流,通过改良引流装置,持续对脑脊液进行引流,保持每日颅内压<200mmH2O;当颅内压<200mmH2O达2天或2天以上时,可停止引流。

干预措施代码:

Intervention:

When the initial intracranial pressure is ≥250mmH2O, the drainage is given, and the cerebrospinal fluid is continuously drained by the improved drainage device to maintain the daily intracranial pressure <200mmH2O; when the intracranial pressure is <200mmH2O for 2 days or more, Stop drainage.

Intervention code:

组别:

任务三, 对照组

样本量:

100

Group:

Task 3, Control group

Sample size:

干预措施:

两性霉素B脱氧胆酸盐联合氟胞嘧啶抗隐球菌治疗。具体实施方案:两性霉素B脱氧胆酸盐0.5 – 0.7mg/kg,每日一次,静脉滴注;氟胞嘧啶,每日100mg/kg,分4次,口服。根据受试者病情及症状行腰椎穿刺并复查脑脊液生化常规、脑脊液墨汁染色及真菌培养。连续抗真菌治疗至少14天,若受试者临床症状改善并且连续两次脑脊液真菌培养均为阴性,则停两性霉素B脱氧胆酸盐及氟胞嘧啶,改为口服氟康唑800 mg/日,继续巩固治疗8周;之后改为口服氟康唑200mg/日继续治疗1年。

干预措施代码:

Intervention:

Amphotericin B deoxycholate combined with flucytosine. Details: amphotericin B deoxycholate 0.5 - 0.7mg / kg, once a day, intravenous drip; flucytosine, daily 100mg / kg, divided into 4 times, PO. Lumbar puncture, biochemical examination of cerebrospinal fluid, cerebrospinal fluid ink staining and fungal culture were p

Intervention code:

组别:

任务三,干预组1

样本量:

100

Group:

Task 3, Intervention group 1

Sample size:

干预措施:

伏立康唑联合氟胞嘧啶抗隐球菌治疗。具体实施方案:伏立康唑,首日诱导剂量为400mg,12小时1次,口服;次日改为维持剂量200mg,12小时1次,口服;氟胞嘧啶,每日100mg/kg,分4次给药,口服;根据受试者病情及症状行腰椎穿刺并复查脑脊液生化常规、脑脊液墨汁染色及真菌培养。连续抗真菌治疗至少14天,若受试者临床症状改善并且连续两次脑脊液真菌培养均为阴性,则停伏立康唑及氟胞嘧啶,改为氟康唑400mg/日,继续巩固治疗8周;之后改为氟康唑200mg/日继续治疗1年。

干预措施代码:

Intervention:

Voriconazole combined with flucytosine. Details: Voriconazole was given orally at the induction dose of 400 mg on the first day, once every 12 hours, 200 mg on the second day, once every 12 hours, and flucytosine at the dose of 100 mg/kg per day, four times a day. Lumbar puncture, biochemical ex

Intervention code:

组别:

任务三,干预组2

样本量:

100

Group:

Task 3, Intervention group 2

Sample size:

干预措施:

两性霉素B脱氧胆酸盐联合氟康唑抗隐球菌治疗。具体实施方案:两性霉素B脱氧胆酸盐0.5 – 0.7mg/kg,每日一次,静脉滴注;氟康唑800mg,每日1次,静脉滴注。根据受试者病情及症状行腰椎穿刺并复查脑脊液生化常规、脑脊液墨汁染色及真菌培养。连续抗真菌治疗至少14天,若受试者临床症状改善并且连续两次脑脊液真菌培养均为阴性,则停用两性霉素B脱氧胆酸盐,改为口服氟康唑400mg/日,继续巩固治疗8周;之后改为口服氟康唑200mg/日继续治疗1年。

干预措施代码:

Intervention:

Amphotericin B deoxycholate combined with fluconazole. Details: Amphotericin B deoxycholate 0.5-0.7 mg/kg, once a day, intravenous drip; fluconazole 800 mg, once a day, intravenous drip. Lumbar puncture, biochemical examination of cerebrospinal fluid, cerebrospinal fluid ink staining and fungal culture were performed according to&

Intervention code:

组别:

任务三,干预组3

样本量:

100

Group:

Task 3, Intervention group 3

Sample size:

干预措施:

两性霉素B脱氧胆酸盐联合伏立康唑抗隐球菌治疗。具体实施方案:伏立康唑,首日诱导剂量为400mg,12小时1次,口服;次日改为维持剂量200mg,12小时1次,口服;两性霉素B脱氧胆酸盐 0.5-0.7mg/kg,每日一次,静脉滴注;根据受试者病情及症状行腰椎穿刺并复查脑脊液生化常规、脑脊液墨汁染色及真菌培养。连续抗真菌治疗至少14天,受试者临床症状改善并且连续两次脑脊液真菌培养均为阴性,停用两性霉素B脱氧胆酸盐及伏立康唑,改为口服氟康唑400mg/日,继续巩固治疗8周;之后改为口服氟康唑200mg/日继续治疗1年。

干预措施代码:

Intervention:

Amphotericin B deoxycholate combined with voriconazole. Details: Voriconazole was administered orally at the induction dose of 400 mg on the first day, once every 12 hours; the maintenance dose of 200 mg on the next day, once every 12 hours; amphotericin B deoxycholate 0.5-0.7 mg/kg once a day, intravenous&

Intervention code:

组别:

任务四,早期ART组

样本量:

50

Group:

Task 4, Early ART group

Sample size:

干预措施:

受试者抗隐球菌治疗2周即启动ART

干预措施代码:

Intervention:

Subjects start ART after 2 weeks of treatment for cryptococcosis.

Intervention code:

组别:

任务四,延迟ART组

样本量:

50

Group:

Task 4, Delayed ART group

Sample size:

干预措施:

抗隐球菌治疗5周后再启动ART。

干预措施代码:

Intervention:

Subjects start ART after 5 weeks of treatment for cryptococcosis.

Intervention code:

组别:

任务五,A组

样本量:

100

Group:

Task 5, Group A

Sample size:

干预措施:

复方新诺明1.44g q8h 口服,联合阿奇霉素0.5 g qd 静脉给药,疗程至少6周。

干预措施代码:

Intervention:

SMZ-TMP 1.44g PO q8h + azithromycin 0.5 g IV qd at least for 6 weeks.

Intervention code:

组别:

任务五,B组

样本量:

100

Group:

Task 5, Group B

Sample size:

干预措施:

增效联磺1.44g q8h口服,联合克林霉素 600 mg q6h静脉给药,疗程至少6周。

干预措施代码:

Intervention:

Sulfamethoxazole,Sulfadiazine and Trimethoprim Tablets 1.44g PO q8h + Clindamycin 600mg IV q8h at least for 6 weeks.

Intervention code:

组别:

任务六,早期ART组

样本量:

100

Group:

Task 6, Early ART group

Sample size:

干预措施:

受试者抗弓形虫治疗2周即启动ART

干预措施代码:

Intervention:

Subjects start ART within 2 weeks of treatment for Toxoplasma gondii.

Intervention code:

组别:

任务六,延迟ART组

样本量:

100

Group:

Task 6,Delayed ART group

Sample size:

干预措施:

抗弓形虫治疗2周后再启动ART

干预措施代码:

Intervention:

Subjects start ART after 2 weeks of treatment for Toxoplasma gondii.

Intervention code:

组别:

任务七 , A组

样本量:

200

Group:

Task 7, Group A

Sample size:

干预措施:

TMP-SMZ(TMP 15-20mg/kg/d,SMX 75-100 mg/kg/d)+泼尼松(40mg 2次/日,5天;40mg 1次/日,5天;20mg 1次/日,11天),总疗程3-4周

干预措施代码:

Intervention:

TMP-SMZ (TMP 15-20 mg/kg/d, SMX 75-100 mg/kg/d) plus prednisone (40 mg 2 times/day, 5 days; 40 mg 1 times/day, 5 days; 20mg 1 time/day, 11 days), total course of treatment 3-4 weeks

Intervention code:

组别:

任务七 , B组

样本量:

200

Group:

Task 7, Group B

Sample size:

干预措施:

TMP-SMZ(TMP 15-20mg/kg/d,SMX 75-100 mg/kg/d)+克林霉素(0.6g克林霉素+100ml 生理盐水缓慢滴注,1 次/6h)+泼尼松(40mg 2次/日,5天;40mg 1次/日,5天;20mg 1次/日,11天) ,总疗程3-4周.

干预措施代码:

Intervention:

TMP-SMZ (TMP 15-20mg/kg/d, SMX 75-100 mg/kg/d) plus clindamycin (0.6g clindamycin combine with 100ml saline slow) Instillation, 1 time / 6h) plus prednisone (40mg 2 times / day, 5 days; 40mg 1 time / day, 5 days; 20mg 1 time / day, 11 days), the total course of treatment 3-4 weeks.

Intervention code:

组别:

任务七 , C组

样本量:

200

Group:

Task 7, Group C

Sample size:

干预措施:

卡泊芬净(70mg 1次/日,1天;50mg 1次/日,20天)+TMP-SMZ(TMP 15-20mg/kg/d,SMX 75-100 mg/kg/d)+泼尼松(40mg 2次/日,5天;40mg 1次/日,5天;20mg 1次/日,11天) ,总疗程3-4周。

干预措施代码:

Intervention:

Caspofungin (70 mg once daily, 1 day; 50 mg once daily, 20 days) combine with TMP-SMZ (TMP 15-20 mg/kg/d, SMX 75-100 mg/kg/d) plus prednisone (40 mg twice daily, 5 days; 40 mg once daily, 5 days; 20 mg once daily, 11 days), total course of treatment 3-4 weeks.

Intervention code:

组别:

任务八,早期ART组

样本量:

100

Group:

Task 8, Early ART group

Sample size:

干预措施:

受试者抗PCP治疗1周内启动ART;

干预措施代码:

Intervention:

Subjects start ART within 1 weeks of treatment for Pneumocystis jirovecii.

Intervention code:

组别:

任务八,延迟ART组

样本量:

100

Group:

Task 6, Delayed ART group

Sample size:

干预措施:

抗PCP治疗2周再启动ART。

干预措施代码:

Intervention:

Subjects start ART after 2 weeks of treatment for Pneumocystis jirovecii.

Intervention code:

组别:

任务九,A组

样本量:

100

Group:

Task 9, Group A

Sample size:

干预措施:

诱导治疗:膦甲酸钠60mg/kg,q8h,静滴时间>2h,疗程2周;维持治疗:膦甲酸钠90mg/kg/day,静滴时间>2 h,疗程至少2周。同时联合地塞米松5 mg qd静脉滴注连续使用4周。

干预措施代码:

Intervention:

Induction therapy: sodium foscarnet 60mg/kg, q8h, infusion time > 2h, 2 weeks of treatment; maintenance treatment: sodium foscarnet 90mg/kg/day, intravenous infusion time > 2 h, treatment for at least 2 weeks. At the same time, dexamethasone 5 mg qd was administered intravenously for 4 weeks.

Intervention code:

组别:

任务九,B组

样本量:

100

Group:

Task 9, Group B

Sample size:

干预措施:

膦甲酸钠60mg/kg,q8h,静滴时间>2h,疗程2周;维持治疗:膦甲酸钠90mg/kg/day,静滴时间>2 h,疗程至少2周。同时联合更昔洛韦0.2~0.4mg qw球内注射连续使用3周。

干预措施代码:

Intervention:

induction therapy: sodium foscarnet 60mg/kg, q8h, intravenous infusion time > 2h, 2 weeks of treatment; maintenance treatment: sodium foscarnet 90mg/kg/day, intravenous infusion time > 2 h, treatment for at least 2 weeks . At the same time, combined with ganciclovir 0.2 ~ 0.4mg qw intra-balloon injection for

Intervention code:

组别:

任务九,C组

样本量:

100

Group:

Task 9, Group C

Sample size:

干预措施:

膦甲酸钠60mg/kg,q8h,静滴时间>2h,疗程2周;维持治疗:膦甲酸钠90mg/kg/day,静滴时间>2h,疗程至少2周。

干预措施代码:

Intervention:

induction therapy: sodium foscarnet 60mg/kg, q8h, infusion time > 2h, 2 weeks of treatment; maintenance treatment: sodium foscarnet 90mg/kg/day, intravenous infusion time > 2h, treatment for at least 2 weeks.

Intervention code:

组别:

任务十,早期ART组

样本量:

150

Group:

Task 10, Early ART group

Sample size:

干预措施:

抗CMV治疗2周内启动ART

干预措施代码:

Intervention:

Subjects start ART within 2 weeks of treatment for CMV.

Intervention code:

组别:

任务十,延迟ART组

样本量:

150

Group:

Task 10, Delayed ART group

Sample size:

干预措施:

抗CMV治疗2周后启动ART

干预措施代码:

Intervention:

Subjects start ART after 2 weeks of treatment for CMV.

Intervention code:

组别:

任务十一,A组

样本量:

80

Group:

Task 11, Group A

Sample size:

干预措施:

两性霉素B脱氧胆酸盐,先静滴2周,第1天给药剂量为5 mg,第2天给药剂量为15 mg,第3天及以后按0.5~0.7 mg/kg/d给药,再改成口服伊曲康唑胶囊200 mg q12 h 10周,总疗程12周。

干预措施代码:

Intervention:

The amphotericin B deoxycholate was given intravenously for 2 weeks, the dose was 5 mg on the first day, 15 mg on the second day, and 0.5-0.7 mg/kg/d on the third day and later. Then changed to oral itraconazole capsule 200 mg q12 h for 10 weeks, the total course of treatment for 12

Intervention code:

组别:

任务十一,B组

样本量:

80

Group:

Task 11, Group B

Sample size:

干预措施:

伏立康唑4 mg/kg q12 h 4天,第1天给予负荷剂量(伏立康唑6 mg/kg q12 h),4天后再改成口服伏立康唑胶囊200 mg q12h,共使用伏立康唑2周后,再改为口服伊曲康唑200 mg q12 h 10周,总疗程12周。

干预措施代码:

Intervention:

Voriconazole 4 mg/kg q12h for 4 days, the first day was given a loading dose (voriconazole 6 mg / kg q12 h). After 4 days, it was changed to oral voriconazole capsule 200 mg q12h. After 2 weeks of voriconazole, it was changed to oral itraconazole 200 mg q12 h for 10 weeks. The total&

Intervention code:

组别:

任务十一,C组

样本量:

80

Group:

Task 11, Group C

Sample size:

干预措施:

伏立康唑4 mg/kg q12 h 2周,第1天给予负荷剂量(伏立康唑6mg/kg q12 h),再改成口服伏立康唑胶囊200 mg q12h?10周,总疗程12周。

干预措施代码:

Intervention:

Voriconazole 4 mg/kg q12h for 2 weeks,the first day was given a loading dose (voriconazole 6mg/kg q12h), and then changed to oral voriconazole capsule 200 mg q12h for 10 weeks, the total course of treatment for 12 weeks.

Intervention code:

组别:

任务十二,早期ART组

样本量:

180

Group:

Task 12, Early ART group

Sample size:

干预措施:

抗马尔尼菲篮状菌治疗2周内启动ART。

干预措施代码:

Intervention:

Subjects start ART within 2 weeks of treatment for Talaromyces marneffei.

Intervention code:

组别:

任务十二,晚期ART组

样本量:

180

Group:

Task 12, Delayed ART group

Sample size:

干预措施:

抗马尔尼菲篮状菌治疗2周后启动ART。

干预措施代码:

Intervention:

Subjects start ART after 2 weeks of treatment for Talaromyces marneffei.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共卫生医疗救治中心 

单位级别:

三级 

Institution
hospital:

Chongqing Public health medical center  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

长沙市第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Changsha  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Youan Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学 

单位级别:

三级甲等 

Institution
hospital:

Harbin Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Second People's Hospital of Tianjin  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市第八人民医院 

单位级别:

三级 

Institution
hospital:

The Eighth People's Hospital of Guangzhou  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

柳州市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Liuzhou General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

桂林市第三人民医院 

单位级别:

二级甲等 

Institution
hospital:

The Third People's Hospital of Guilin  

Level of the institution:

Second A Hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

吉林大学 

单位级别:

大学 

Institution
hospital:

Jilin University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

隐脑发生率

指标类型:

主要指标 

Outcome:

Incidence of cryptococcal meningitis

Type:

Primary indicator 

测量时间点:

隐球菌脑膜炎治疗46周期间

测量方法:

Measure time point of outcome:

during the 46 weeks of treatment for cryptococcal meningitis

Measure method:

指标中文名:

隐球菌抗原转阴率

指标类型:

主要指标 

Outcome:

Cryptococcal antigen conversion rate

Type:

Primary indicator 

测量时间点:

隐球菌脑膜炎治疗46周期间

测量方法:

Measure time point of outcome:

During the 46 weeks of treatment for cryptococcal meningitis

Measure method:

指标中文名:

隐球菌抗原滴度

指标类型:

次要指标 

Outcome:

Cryptococcal antigen titer

Type:

Secondary indicator 

测量时间点:

隐球菌脑膜炎治疗46周期间

测量方法:

Measure time point of outcome:

During 46 weeks of treatment for cryptococcal meningitis

Measure method:

指标中文名:

隐球菌脑病病死率

指标类型:

主要指标 

Outcome:

Mortality of cryptococcal meningitis

Type:

Primary indicator 

测量时间点:

颅内压管理46周后

测量方法:

Measure time point of outcome:

After 46 weeks of intracranial pressure management

Measure method:

指标中文名:

颅内压

指标类型:

主要指标 

Outcome:

Intracranial pressure

Type:

Primary indicator 

测量时间点:

颅内压管理46周期间

测量方法:

Measure time point of outcome:

During 46 weeks of intracranial pressure management

Measure method:

指标中文名:

隐脑致残率

指标类型:

次要指标 

Outcome:

Disability rate of cryptococcal meningitis

Type:

Secondary indicator 

测量时间点:

颅内压管理46周后

测量方法:

Measure time point of outcome:

After intracranial pressure management for 46 weeks

Measure method:

指标中文名:

脑脊液生化常规

指标类型:

次要指标 

Outcome:

Cerebrospinal fluid biochemical routine

Type:

Secondary indicator 

测量时间点:

隐球菌脑膜炎46周期间

测量方法:

Measure time point of outcome:

During 46 weeks of treatment for cryptococcal meningitis

Measure method:

指标中文名:

头颅影像学检查

指标类型:

附加指标 

Outcome:

Imaging findings

Type:

Additional indicator 

测量时间点:

隐球菌脑膜炎46周期间

测量方法:

Measure time point of outcome:

During 46 weeks of treatment for cryptococcal meningitis

Measure method:

指标中文名:

脑脊液内炎症因子的变化

指标类型:

附加指标 

Outcome:

Changes in inflammatory factors in cerebrospinal fluid

Type:

Additional indicator 

测量时间点:

隐球菌脑膜炎46周期间

测量方法:

Measure time point of outcome:

During 46 weeks of treatment for cryptococcal meningitis

Measure method:

指标中文名:

IRIS发生率

指标类型:

次要指标 

Outcome:

Incidence of IRIS

Type:

Secondary indicator 

测量时间点:

ART48周内

测量方法:

Measure time point of outcome:

During 48 weeks of ART

Measure method:

指标中文名:

弓形虫脑病疗效

指标类型:

主要指标 

Outcome:

Response rate of Toxoplasmic encephalitis

Type:

Primary indicator 

测量时间点:

弓形虫脑病治疗12周后

测量方法:

Measure time point of outcome:

After 12 weeks of treatment for Toxoplasmic encephalitis

Measure method:

指标中文名:

弓形虫脑病病死率

指标类型:

主要指标 

Outcome:

Mortality of Toxoplasmic encephalitis

Type:

Primary indicator 

测量时间点:

弓形虫脑病治疗12周后

测量方法:

Measure time point of outcome:

After 12 weeks of treatment for Toxoplasmic encephalitis

Measure method:

指标中文名:

弓形虫脑病治疗方案安全性

指标类型:

副作用指标 

Outcome:

Safety of treatment for Toxoplasmic encephalitis

Type:

Adverse events 

测量时间点:

弓形虫脑病治疗12周内

测量方法:

Measure time point of outcome:

During 12 weeks of treatment for Toxoplasmic encephalitis

Measure method:

指标中文名:

PCP疗效

指标类型:

主要指标 

Outcome:

Response rate of PCP

Type:

Primary indicator 

测量时间点:

PCP治疗12周后

测量方法:

Measure time point of outcome:

After 12 weeks of treatment for PCP

Measure method:

指标中文名:

PCP病死率

指标类型:

主要指标 

Outcome:

Mortality of PCP

Type:

Primary indicator 

测量时间点:

PCP治疗12周后

测量方法:

Measure time point of outcome:

After 12 weeks of treatment for PCP

Measure method:

指标中文名:

PCP治疗方案安全性

指标类型:

副作用指标 

Outcome:

Safety of treatment for PCP

Type:

Adverse events 

测量时间点:

PCP治疗12周内

测量方法:

Measure time point of outcome:

During 12 weeks of treatment for PCP

Measure method:

指标中文名:

CMV病死率

指标类型:

主要指标 

Outcome:

Mortality of CMV

Type:

Primary indicator 

测量时间点:

CMV治疗24周后

测量方法:

Measure time point of outcome:

After 24 weeks of treatment for CMV

Measure method:

指标中文名:

抗CMV疗效

指标类型:

主要指标 

Outcome:

Response rate of treatment for CMV

Type:

Primary indicator 

测量时间点:

CMV治疗24周后

测量方法:

Measure time point of outcome:

After 24 weeks of treatment for CMV

Measure method:

指标中文名:

CMV治疗方案安全性

指标类型:

副作用指标 

Outcome:

Safety of treatment for CMV

Type:

Adverse events 

测量时间点:

CMV治疗24周内

测量方法:

Measure time point of outcome:

During 24 weeks of treatment for CMV

Measure method:

指标中文名:

眼部症状

指标类型:

主要指标 

Outcome:

Eye symptom

Type:

Primary indicator 

测量时间点:

ART48周内

测量方法:

Measure time point of outcome:

During 48 weeks of ART

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

脑脊液

组织:

Sample Name:

cerebrospinal fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

房水

组织:

Sample Name:

aqueous fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

大便

组织:

Sample Name:

excrement

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

痰液

组织:

Sample Name:

sputamentum

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

皮肤组织

组织:

Sample Name:

skin tissue

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

口腔黏膜

组织:

Sample Name:

mucous membrane of mouth

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

研究者采用电子数据平台产生随机号。

Randomization Procedure (please state who generates the random number sequence and by what method):

Researchers use electronic data platform to generate random numbers.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成后6个月内发表论文

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Publish papers within six months after the trial complete

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据管理 本研究采用医研通数据平台进行电子化数据管理,在试验启动之前对参加人员进行相关培训。数据管理方根据病例报告表构建e-CRF,并根据研究者提供的信息创建账号。 1 数据记录 1)研究者填写临床试验记录要求:及时、准确、完整、规范、真实; 2)全部病例均按方案规定,认真书写病历和病例报告表,所有项目均需填写,不得空项、漏项(无记录的空格划斜线)。 3)病历及病例报告表作为原始记录,做任何更正时只能划线,旁注修改后数据,说明理由并由参加临床试验的医师和研究者签名并注明日期,不得擦涂、覆盖原始记录。 4)化验单齐全并粘贴在病例报告表上,病例报告表记录的数据要与病历及原始检验报告核对无误。 5)对显著异常或在临床可接受范围以外的数据(实验室检查项目超过正常值的20%)需加以合适,由参加临床试验的医师做必要的说明。 6)每一位受试者观察疗程结束后,研究者应在3个工作日内将病例报告表及病历交本单位主要研究者审核、签名。 2 数据监察 1)主研单位质控人员在试验过程中要核查研究者是否遵循试验方案,定期去各试验中心检查受试者的知情同意及筛选纳入情况; 2)确认所有病例报告表填写及时、正确,并与原始资料真实、一致;所有错误或遗漏均已改正或注明,经研究者签名并注明日期;每一受试者的剂量改变、治疗变更、合并用药、间发疾病、检查遗漏等均应确认并记录; 3)核实入选受试者的退出须在病例报告表中予以说明;确认所有不良事件均应记录在案,严重不良事件在规定时间内作出报告并记录在案;核实试验用药品是否按照有关规定进行供应、储藏、分发、回收,并做相应的记录。 3 数据保存 1)建立数据库:根据病例报告表的项目采用医研通数据平台建立相应录入程序,并设定录入时的逻辑审查限定条件,对数据库进行试运行,建立本试验专用的数据库系统。 2)录入前再次核查:对病例报告表进一步检查。已经审核声明签字的病例报告表交数据管理员,数据管理员对日期、入组标准、排除标准、脱落、缺失值等进行检查,如有疑问,可填写疑问表返回检察员,由研究者对疑问表中的问题进行书面解答并签名,交回数据管理员,疑问表应妥善保管。 3)数据录入:e-CRF数据来源于原始记录,由研究者根据e-CRF填写说明,将受试者研究数据及时录入医研通数据平台中,保证数据的真实、准确、完整、及时,并需确保与受试者原始病历数据核对一质性。 4)数据审核:采用计算机软件中的核查功能进行逻辑检查与自动比较,查对与病例报告表不一致的结果值,然后逐项与原始病例报告表核对,予以更正。再进行病例报告表和数据库中的数据与病例报告表中的结果一致。 5)数据锁定:由主要研究者、申办者,统计分析人员和数据管理人员共同签署数据锁定记录后,数据管理员进行数据库锁定。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data Management In this study, the medical research and development data platform was used for electronic data management, and participants were trained before the trial started. The data management party builds an e-CRF based on the case report form and creates an account based on the information provided by the researcher. 1. Data Recording 1) The researcher fills in the clinical test record requirements: timely, accurate, complete, standardized, and true; 2) All cases are written according to the regulations, and the medical records and case report forms are carefully written. All items need to be filled out, and no empty items or missing items (with no recorded spaces); 3) The medical record and case report form are used as the original records. Any corrections can only be crossed, and the revised data should be inserted. The reasons are indicated and signed and dated by the doctors and researchers participating in the clinical trial. recording; 4) The test list is complete and pasted on the case report form, and the data recorded in the case report form should be checked against the medical record and the original test report; 5) Appropriate abnormality or data outside the clinically acceptable range (laboratory items exceeding 20% of the normal value) should be appropriate, and the necessary explanation should be given by the physician participating in the clinical trial; 6) After the end of the observation course, the investigator shall review and sign the case report form and the medical record to the main investigator of the unit within 3 working days; 2. Data monitoring 1) The quality control personnel of the main research unit should check whether the researcher follows the test plan during the test, and regularly go to each test center to check the subject's informed consent and screening and inclusion; 2) Confirm that all case report forms are filled in correctly and correctly, and are true and consistent with the original materials; all errors or omissions have been corrected or indicated, signed and dated by the investigator; dose change and treatment of each subject Changes, combined medications, intermittent illnesses, and omissions should be confirmed and recorded; 3) Verification of the withdrawal of the selected subjects shall be stated in the case report form; confirmation that all adverse events shall be recorded, serious adverse events shall be reported and recorded within the specified time; verification of whether the test drugs are in accordance with relevant regulations Supply, store, distribute, recycle, and record accordingly. 3 data saving 1) Establish database: According to the project of the case report form, use the medical research data platform to establish the corresponding entry procedure, and set the logical review qualification conditions at the time of entry, test run the database, and establish a database system dedicated to the test; 2) Check again before entering: further check the case report form. The case report form signed by the audited statement is submitted to the data administrator. The data manager checks the date, the entry criteria, the exclusion criteria, the dropout, the missing value, etc. If in doubt, you can fill in the question form and return to the inspector. The questions in the question form are answered in writing and signed, and returned to the data administrator. The question form should be kept in a safe place; 3) Data entry: The e-CRF data is derived from the original record. The researcher fills in the e-CRF instructions and records the subject research data into the medical research data platform in time to ensure the data is true, accurate, complete and timely. It is also necessary to ensure that the original medical record data of the subject is checked for qualitative; 4) Data audit: Use the verification function in the computer software to perform logical check and automatic comparison, check the result value that is inconsistent with the case report form, and then check the original case report form item by item and correct it. The data in the case report form and the database are consistent with the results in the case report form; 5) Data lock: After the data lock record is signed by the main researcher, sponsor, statistical analyst and data management personnel, the data administrator performs database lock.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-02-01
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