儿童接触和感染 HIV 的长期影响
儿科晚期结果协议
由于开发了新的药物和疫苗来预防 HIV 疾病的进展和延长 HIV 感染患者的生存期,因此在研究中评估了这些治疗的短期安全性和有效性。
然而,长期影响,无论是好处还是副作用,也需要研究。
这些长期影响可能对仍在生长发育中的婴儿和儿童产生更大的影响。
本研究的目的是跟踪在儿科艾滋病临床试验组 (PACTG) 研究地点观察到的暴露于 HIV 和感染 HIV 的婴儿、儿童和青少年。
将观察这些患者的长期益处或药物或疫苗的任何晚期有害影响。
研究概览
详细说明
在大多数临床试验的时间范围内,无法评估新型抗 HIV 疗法的潜在长期益处、毒性和其他不良后果。 有必要更好地评估正负晚期结果和晚期治疗对成长中儿童的影响。 这项前瞻性纵向研究将评估这些影响及其对儿童的影响。
本研究中的儿童将包括感染 HIV 的患者、在出生前或出生时接触过 HIV 或抗 HIV 药物的患者,或在儿科艾滋病临床试验组 (PACTG) 站点随访的患者的孩子。 孩子们将在生命的第一年每 3 个月进行一次研究访问。 1 岁以后,感染 HIV 的儿童将继续每 3 个月进行一次研究访问,而未感染 HIV 的儿童将每年进行一次研究访问。 研究评估将包括完整的身体检查、病史、Tanner 分期、神经系统检查、生长和生活质量评估,以及血液学、化学和尿液分析等实验室测试。 并非所有评估都将在每次研究访视时进行。 患者将被随访至 24 岁。
研究类型
观察性的
注册
4150
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Bayamon、波多黎各、00956
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
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San Juan、波多黎各、009367344
- San Juan City Hosp
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San Juan、波多黎各、009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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-
-
-
Alabama
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Birmingham、Alabama、美国、35233
- Univ of Alabama at Birmingham - Pediatric
-
Mobile、Alabama、美国、36604
- Univ of South Alabama
-
-
Arizona
-
Phoenix、Arizona、美国、85006
- Phoenix Childrens Hosp
-
-
California
-
La Jolla、California、美国、920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
-
Long Beach、California、美国、90801
- Long Beach Memorial (Pediatric)
-
Los Angeles、California、美国、900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
-
Los Angeles、California、美国、90033
- Los Angeles County - USC Med Ctr
-
Los Angeles、California、美国、900481804
- Cedars Sinai / UCLA Med Ctr
-
Los Angeles、California、美国、900951752
- UCLA Med Ctr / Pediatric
-
Los Angeles、California、美国、90095
- UCLA Med Ctr / Pediatrics
-
Los Angeles、California、美国、90095
- UCLA Med Ctr
-
Oakland、California、美国、946091809
- Children's Hosp of Oakland
-
San Francisco、California、美国、94110
- San Francisco Gen Hosp
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San Francisco、California、美国、941430105
- UCSF / Moffitt Hosp - Pediatric
-
-
Connecticut
-
Farmington、Connecticut、美国、06032
- Univ of Connecticut / Farmington
-
Farmington、Connecticut、美国、060303805
- Connecticut Children's Med Ctr
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New Haven、Connecticut、美国、06504
- Yale Univ Med School
-
-
District of Columbia
-
Washington、District of Columbia、美国、20060
- Howard Univ. Washington DC NICHD CRS
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Washington、District of Columbia、美国、200102916
- Children's Hosp of Washington DC
-
-
Florida
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Fort Lauderdale、Florida、美国、33311
- North Broward Hosp District
-
Gainesville、Florida、美国、32610
- Univ of Florida Gainesville
-
Jacksonville、Florida、美国、32209
- Univ of Florida Health Science Ctr / Pediatrics
-
Miami、Florida、美国、33161
- Univ of Miami (Pediatric)
-
Miami、Florida、美国、33136
- Univ of Miami / Jackson Memorial Hosp
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Pensacola、Florida、美国、32503
- Sacred Heart Children's Hosp / CMS of Florida
-
Riviera Beach、Florida、美国、33404
- Palm Beach County Health Dept
-
St. Petersburg、Florida、美国、33701
- Univ of South Florida
-
-
Georgia
-
Atlanta、Georgia、美国、30306
- Emory Univ Hosp / Pediatrics
-
Augusta、Georgia、美国、30912
- Med College of Georgia
-
Columbus、Georgia、美国、31901
- The Med Ctr Inc
-
-
Illinois
-
Chicago、Illinois、美国、60612
- Cook County Hosp
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Chicago、Illinois、美国、606143394
- Chicago Children's Memorial Hosp
-
Chicago、Illinois、美国、606371470
- Univ of Chicago Children's Hosp
-
Chicago、Illinois、美国、60612
- Univ of Illinois College of Medicine / Pediatrics
-
Chicago、Illinois、美国、60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
-
-
Louisiana
-
New Orleans、Louisiana、美国、701122699
- Tulane Univ / Charity Hosp of New Orleans
-
New Orleans、Louisiana、美国、70112-2699
- Children's Hospital of New Orleans
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New Orleans、Louisiana、美国、70112
- Earl K Long Early Intervention Clinic
-
New Orleans、Louisiana、美国、70112
- Univ Hosp
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- Univ of Maryland at Baltimore / Univ Med Ctr
-
Baltimore、Maryland、美国、212874933
- Johns Hopkins Hosp - Pediatric
-
-
Massachusetts
-
Boston、Massachusetts、美国、021155724
- Children's Hosp of Boston
-
Boston、Massachusetts、美国、02118
- Boston City Hosp / Pediatrics
-
Boston、Massachusetts、美国、02115
- Childrens Hospital of Boston
-
Springfield、Massachusetts、美国、01199
- Baystate Med Ctr of Springfield
-
Worcester、Massachusetts、美国、016550001
- Univ of Massachusetts Med School
-
-
Michigan
-
Detroit、Michigan、美国、48201
- Children's Hosp of Michigan
-
-
Mississippi
-
Jackson、Mississippi、美国、39213
- Univ of Mississippi Med Ctr
-
-
Missouri
-
St. Louis、Missouri、美国、63110
- St. Louis Children's Hosp
-
-
New Jersey
-
Camden、New Jersey、美国、081031438
- Cooper Hosp
-
New Brunswick、New Jersey、美国、089030019
- UMDNJ - Robert Wood Johnson Med School / Pediatrics
-
New Brunswick、New Jersey、美国、08901-1969
- Robert Wood Johnson AIDS Program
-
Newark、New Jersey、美国、071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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Newark、New Jersey、美国、07103
- Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
-
-
New York
-
Albany、New York、美国、12208
- Children's Hosp at Albany Med Ctr
-
Bronx、New York、美国、10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
-
Bronx、New York、美国、10467
- Montefiore Med Ctr Adolescent AIDS Program
-
Bronx、New York、美国、10457
- Bronx Lebanon Hosp Ctr
-
Bronx、New York、美国、19461
- Montefiore Medical / AECOM
-
Brooklyn、New York、美国、11203
- SUNY - Brooklyn
-
Great Neck、New York、美国、11021
- North Shore Univ Hosp
-
New Hyde Park、New York、美国、11040
- Schneider Children's Hosp
-
New York、New York、美国、10016
- Bellevue Hosp / New York Univ Med Ctr
-
New York、New York、美国、10029
- Metropolitan Hosp Ctr
-
New York、New York、美国、10021
- Cornell Univ Med College
-
New York、New York、美国、10032
- Columbia Presbyterian Med Ctr
-
New York、New York、美国、10032
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
-
New York、New York、美国、10037
- Harlem Hosp Ctr
-
New York、New York、美国、10029
- Mount Sinai Med Ctr / Pediatrics
-
New York、New York、美国、10021
- New York Hosp - Cornell Med Ctr
-
New York、New York、美国、10003
- Beth Israel Med Ctr / Pediatrics
-
Rochester、New York、美国、146420001
- Univ of Rochester Med Ctr
-
Stony Brook、New York、美国、117948111
- State Univ of New York at Stony Brook
-
Syracuse、New York、美国、13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
-
-
North Carolina
-
Durham、North Carolina、美国、277103499
- Duke Univ Med Ctr
-
Durham、North Carolina、美国、27710
- Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
-
-
Ohio
-
Columbus、Ohio、美国、432052696
- Columbus Children's Hosp
-
-
Oregon
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Portland、Oregon、美国、97201
- Oregon Health Sciences Univ
-
-
Pennsylvania
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Philadelphia、Pennsylvania、美国、191044318
- Children's Hosp of Philadelphia
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Philadelphia、Pennsylvania、美国、191341095
- Saint Christopher's Hosp for Children
-
-
Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hosp / Brown Univ
-
-
South Carolina
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Charleston、South Carolina、美国、294253312
- Med Univ of South Carolina
-
-
Tennessee
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Memphis、Tennessee、美国、381052794
- Saint Jude Children's Research Hosp of Memphis
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Nashville、Tennessee、美国、372322581
- Vanderbilt Univ Med Ctr
-
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Texas
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Dallas、Texas、美国、75235
- Children's Med Ctr of Dallas
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Houston、Texas、美国、77030
- Texas Children's Hosp / Baylor Univ
-
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Virginia
-
Norfolk、Virginia、美国、23507
- Children's Hosp of the King's Daughters
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Richmond、Virginia、美国、23219
- Med College of Virginia
-
-
Washington
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Seattle、Washington、美国、981050371
- Children's Hospital & Medical Center / Seattle ACTU
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1天 至 21年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准
- 21 岁或以下(如果未满 18 岁,则需要父母或监护人的同意)。
- 满足以下 3 项要求中的一项:1) 参加过本研究的先前版本; 2) 围产期暴露于 HIV、HIV 疫苗或抗逆转录病毒治疗(必须在一岁生日前登记); 3) 在 PACTG 站点跟踪感染 HIV 的婴儿、儿童和青少年(及其后代)。
排除标准
- 无法遵守研究访问时间表。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:James Oleske
- 学习椅:Michael Brady
- 学习椅:Wayne Dankner
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Brady MT, Clark C, Weedy C, Fowler M, Mofenson L, Oleske J. Disclosure of HIV diagnosis to children in ACTG clinical trials (ACTG 219). Int Conf AIDS. 1996 Jul 7-12;11(2):43 (abstract no WeD131)
- Gaughan DM, Mofeson LM, Hughes MD, Seage GR, Oleske JM. Avascular necrosis of the hip (Leggs-Calve-Perthes disease [LCPD]) in HIV-infected children in long-term follow-up: PACTG study 219. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 638)
- Buchacz K, Cervia JS, Lindsey JC, Hughes MD, Seage GR 3rd, Dankner WM, Oleske JM, Moye J. Impact of protease inhibitor-containing combination antiretroviral therapies on height and weight growth in HIV-infected children. Pediatrics. 2001 Oct;108(4):E72. doi: 10.1542/peds.108.4.e72.
- Culnane M, Fowler M, Lee SS, McSherry G, Brady M, O'Donnell K, Mofenson L, Gortmaker SL, Shapiro DE, Scott G, Jimenez E, Moore EC, Diaz C, Flynn PM, Cunningham B, Oleske J. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999 Jan 13;281(2):151-7. doi: 10.1001/jama.281.2.151.
- Gaughan DM, Mofenson LM, Hughes MD, Seage GR 3rd, Ciupak GL, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Osteonecrosis of the hip (Legg-Calve-Perthes disease) in human immunodeficiency virus-infected children. Pediatrics. 2002 May;109(5):E74-4. doi: 10.1542/peds.109.5.e74.
- Hanson IC, Antonelli TA, Sperling RS, Oleske JM, Cooper E, Culnane M, Fowler MG, Kalish LA, Lee SS, McSherry G, Mofenson L, Shapiro DE. Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Apr 15;20(5):463-7. doi: 10.1097/00042560-199904150-00008.
- Gaughan DM, Hughes MD, Seage GR 3rd, Selwyn PA, Carey VJ, Gortmaker SL, Oleske JM. The prevalence of pain in pediatric human immunodeficiency virus/acquired immunodeficiency syndrome as reported by participants in the Pediatric Late Outcomes Study (PACTG 219). Pediatrics. 2002 Jun;109(6):1144-52. doi: 10.1542/peds.109.6.1144.
- Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.
- Howland LC, Gortmaker SL, Mofenson LM, Spino C, Gardner JD, Gorski H, Fowler MG, Oleske J. Effects of negative life events on immune suppression in children and youth infected with human immunodeficiency virus type 1. Pediatrics. 2000 Sep;106(3):540-6. doi: 10.1542/peds.106.3.540.
- Nucleoside exposure in the children of HIV-infected women receiving antiretroviral drugs: absence of clear evidence for mitochondrial disease in children who died before 5 years of age in five United States cohorts. J Acquir Immune Defic Syndr. 2000 Nov 1;25(3):261-8. doi: 10.1097/00126334-200011010-00009.
- Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.
- Farley J, Gona P, Crain M, Cervia J, Oleske J, Seage G, Lindsey J; Pediatric AIDS Clinical Trials Group Study 219C Team. Prevalence of elevated cholesterol and associated risk factors among perinatally HIV-infected children (4-19 years old) in Pediatric AIDS Clinical Trials Group 219C. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):480-7. doi: 10.1097/01.qai.0000139397.30612.96.
- Kest H, Brogly S, McSherry G, Dashefsky B, Oleske J, Seage GR 3rd. Malignancy in perinatally human immunodeficiency virus-infected children in the United States. Pediatr Infect Dis J. 2005 Mar;24(3):237-42. doi: 10.1097/01.inf.0000154324.59426.8d.
- Brogly S, Williams P, Seage GR 3rd, Oleske JM, Van Dyke R, McIntosh K; PACTG 219C Team. Antiretroviral treatment in pediatric HIV infection in the United States: from clinical trials to clinical practice. JAMA. 2005 May 11;293(18):2213-20. doi: 10.1001/jama.293.18.2213.
- Gona P, Van Dyke RB, Williams PL, Dankner WM, Chernoff MC, Nachman SA, Seage GR 3rd. Incidence of opportunistic and other infections in HIV-infected children in the HAART era. JAMA. 2006 Jul 19;296(3):292-300. doi: 10.1001/jama.296.3.292.
- Williams PL, Storm D, Montepiedra G, Nichols S, Kammerer B, Sirois PA, Farley J, Malee K; PACTG 219C Team. Predictors of adherence to antiretroviral medications in children and adolescents with HIV infection. Pediatrics. 2006 Dec;118(6):e1745-57. doi: 10.1542/peds.2006-0493. Epub 2006 Nov 13.
- Sirois PA, Montepiedra G, Kapetanovic S, Williams PL, Pearson DA, Malee K, Garvie PA, Kammerer BL, Nichols SL, Nozyce ML, Mintz M, Mitchell WG, Oleske JM; IMPAACT/PACTG 219C Team. Impact of medications prescribed for treatment of attention-deficit hyperactivity disorder on physical growth in children and adolescents with HIV. J Dev Behav Pediatr. 2009 Oct;30(5):403-12. doi: 10.1097/dbp.0b013e3181ba0cf6.
- Levin MJ, Anderson JP, Seage GR 3rd, Williams PL; PACTG/IMPAACT 219C Team. Short-term and long-term effects of highly active antiretroviral therapy on the incidence of herpes zoster in HIV-infected children. J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):182-91. doi: 10.1097/QAI.0b013e31819550a4.
- Edathodu J, Halim MM, Dahham MB, Alrajhi AA. Mother-to-child transmission of HIV: experience at a referral hospital in Saudi Arabia. Ann Saudi Med. 2010 Jan-Feb;30(1):15-7. doi: 10.4103/0256-4947.59367.
- Kapetanovic S, Aaron L, Montepiedra G, Sirois PA, Oleske JM, Malee K, Pearson DA, Nichols SL, Garvie PA, Farley J, Nozyce ML, Mintz M, Williams PL; Pediatric AIDS Clinical Trials. The use of second-generation antipsychotics and the changes in physical growth in children and adolescents with perinatally acquired HIV. AIDS Patient Care STDS. 2009 Nov;23(11):939-47. doi: 10.1089/apc.2009.0121.
- Nachman SA, Chernoff M, Gona P, Van Dyke RB, Dankner WM, Seage GR 3rd, Oleske J, Williams PL; PACTG 219C Team. Incidence of noninfectious conditions in perinatally HIV-infected children and adolescents in the HAART era. Arch Pediatr Adolesc Med. 2009 Feb;163(2):164-71. doi: 10.1001/archpedi.163.2.164. Erratum In: Arch Pediatr Adolesc Med. 2009 Apr;163(4):364.
- Williams PL, Van Dyke R, Eagle M, Smith D, Vincent C, Ciupak G, Oleske J, Seage GR 3rd; PACTG 219C Team. Association of site-specific and participant-specific factors with retention of children in a long-term pediatric HIV cohort study. Am J Epidemiol. 2008 Jun 1;167(11):1375-86. doi: 10.1093/aje/kwn072. Epub 2008 Apr 15.
- Lyon ME, Williams PL, Woods ER, Hutton N, Butler AM, Sibinga E, Brady MT, Oleske JM. Do-not-resuscitate orders and/or hospice care, psychological health, and quality of life among children/adolescents with acquired immune deficiency syndrome. J Palliat Med. 2008 Apr;11(3):459-69. doi: 10.1089/jpm.2007.0148.
- Lindsey JC, Malee KM, Brouwers P, Hughes MD; PACTG 219C Study Team. Neurodevelopmental functioning in HIV-infected infants and young children before and after the introduction of protease inhibitor-based highly active antiretroviral therapy. Pediatrics. 2007 Mar;119(3):e681-93. doi: 10.1542/peds.2006-1145. Epub 2007 Feb 12.
- Seage GR 3rd, Buchacz K, Weinberg GA, Patel K, McIntosh K, Dankner WM. The Pediatric AIDS Severity Score (PASS): a multidimensional AIDS-severity adjustment for pediatric HIV infection. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):603-10. doi: 10.1097/01.qai.0000242453.20521.4f.
- Williams PL, Marino M, Malee K, Brogly S, Hughes MD, Mofenson LM; PACTG 219C Team. Neurodevelopment and in utero antiretroviral exposure of HIV-exposed uninfected infants. Pediatrics. 2010 Feb;125(2):e250-60. doi: 10.1542/peds.2009-1112. Epub 2010 Jan 18.
- Malee K, Williams PL, Montepiedra G, Nichols S, Sirois PA, Storm D, Farley J, Kammerer B; PACTG 219C Team. The role of cognitive functioning in medication adherence of children and adolescents with HIV infection. J Pediatr Psychol. 2009 Mar;34(2):164-75. doi: 10.1093/jpepsy/jsn068. Epub 2008 Jul 22.
- Kapetanovic S, Aaron L, Williams PL, Farley J, Sirois PA, Garvie PA, Pearson DA, Oleske JM, Montepiedra G; The IMPAACT PACTG 219C Team. Relationships between the use of second-generation antipsychotics and changes in total cholesterol levels in children and adolescents perinatally infected with HIV. Neurobehav HIV Med. 2010 Aug;2010(2):39-48. doi: 10.2147/NBHIV.S12517.
- Malee K, Williams P, Montepiedra G, McCabe M, Nichols S, Sirois PA, Storm D, Farley J, Kammerer B; PACTG 219C Team. Medication adherence in children and adolescents with HIV infection: associations with behavioral impairment. AIDS Patient Care STDS. 2011 Mar;25(3):191-200. doi: 10.1089/apc.2010.0181. Epub 2011 Feb 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
研究完成 (实际的)
2002年5月1日
研究注册日期
首次提交
2000年9月27日
首先提交符合 QC 标准的
2001年8月30日
首次发布 (估计)
2001年8月31日
研究记录更新
最后更新发布 (估计)
2013年10月7日
上次提交的符合 QC 标准的更新
2013年10月4日
最后验证
2013年10月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ACTG 219C
- ACTG 219
- PACTG 219C
- 11196 (注册表标识符:DAIDS ES)
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.
艾滋病毒感染的临床试验
-
Hospital Clinic of Barcelona完全的
-
Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
-
National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
-
AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
-
Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
-
Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的