Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
Perinatal Core Protocol
The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children.
The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.
研究概览
详细说明
The current low rate of vertical transmission of HIV in the U.S. limits the number and types of questions concerning transmission risk and pathogenesis that can be addressed by a single clinical trial. Specific U.S. Public Health Service guidelines recommend antiretroviral therapy (ART) during pregnancy to maximize health of women. However, data regarding the effectiveness and safety of and adherence to ART during pregnancy are limited. It is both appropriate and necessary for theInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) to recruit pregnant women into a non-interventional, analytic, epidemiologic study to methodically collect clinical and laboratory data from them and their infants. This way, the IMPAACT can achieve the aims of evaluating management of HIV-infected women during pregnancy and determining the safety and effectiveness of ART and other interventions intended to prevent vertical transmission and/or improve maternal health. In addition, longitudinally collected core protocol data and repository specimens will enable future substudies.
Participants receive no protocol specific treatment or other intervention as part of this study. The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery for 6 months postpartum and their infants for the first 6 months of life. There will be 8 study visits for enrolled participants and 6 study visits for infants. Data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits. Phlebotomy is conducted to obtain specimens for a repository and for required laboratory tests. During labor and delivery, maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage. Collection of amniotic fluid at the time of cesarean section is encouraged. These collections are submitted to a central repository. Data for the core protocol are abstracted from the infant's medical record at the time of birth and at each postnatal visit.
研究类型
注册 (实际的)
联系人和位置
学习地点
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San Juan、波多黎各、00936-5067
- University of Puerto Rico Pediatric HIV/AIDS (6601)
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San Juan、波多黎各、00936-7344
- San Juan City Hosp. PR NICHD CRS (5031)
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Alabama
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Birmingham、Alabama、美国、35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile、Alabama、美国、36688
- University of South Alabama
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Arizona
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Phoenix、Arizona、美国、85006
- Phoenix Childrens Hospital
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California
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Long Beach、California、美国、90801
- Long Beach Memorial (Pediatric)
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Long Beach、California、美国、90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles、California、美国、900951752
- UCLA Med Ctr / Pediatric
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Los Angeles、California、美国、90033
- Usc La Nichd Crs (5048)
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Los Angeles、California、美国、90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles、California、美国、90033
- Los Angeles County Medical Center/USC
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San Diego、California、美国、92103
- Univ of California, San Diego (4601)
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San Francisco、California、美国、94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance、California、美国、90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver、Colorado、美国、80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington、Connecticut、美国、06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington、Connecticut、美国、06030-3805
- University of Connecticut, Farmington
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New Haven、Connecticut、美国、06504
- Yale Univ School of Med
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District of Columbia
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Washington、District of Columbia、美国、20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington、District of Columbia、美国、200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington、District of Columbia、美国、20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale、Florida、美国、33311
- North Broward Hosp District
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Ft Lauderdal、Florida、美国、33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville、Florida、美国、32209
- University of Florida Jacksonville (5051)
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Miami、Florida、美国、33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami、Florida、美国、33136
- Jackson Memorial Hosp
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St Petersburg、Florida、美国、33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta、Georgia、美国、30912
- Med College of Georgia
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Columbus、Georgia、美国、31901
- The Medical Center
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Illinois
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Chicago、Illinois、美国、60612
- Cook County Hospital
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Chicago、Illinois、美国、60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago、Illinois、美国、60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago、Illinois、美国、60608-1797
- Womens & Childrens HIV Program
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Chicago、Illinois、美国、60612-7234
- Univ of Illinois
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Chicago、Illinois、美国、60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago、Illinois、美国、60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans、Louisiana、美国、70112-2699
- Tulane University New Orleans (5095)
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New Orleans、Louisiana、美国、70112-2699
- Tulane-Lakeside Hospital
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New Orleans、Louisiana、美国、70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore、Maryland、美国、21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston、Massachusetts、美国、02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston、Massachusetts、美国、02118
- Boston Med Ctr (Pediatric) (5011)
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Boston、Massachusetts、美国、02478
- Brigham and Women's Hosp
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Springfield、Massachusetts、美国、01199
- Baystate Med Ctr of Springfield
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Worcester、Massachusetts、美国、01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester、Massachusetts、美国、01655
- Univ of Massachusetts Med School
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Michigan
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Detroit、Michigan、美国、48201-1427
- Hutzel Hospital (5089)
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Detroit、Michigan、美国、48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis、Missouri、美国、63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark、New Jersey、美国、07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark、New Jersey、美国、07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark、New Jersey、美国、07103
- New Jersey Medical School (2802)
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New York
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Bronx、New York、美国、19461
- Montefiore Medical / AECOM
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Bronx、New York、美国、10451
- Lincoln Medical & Mental Health Center
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Bronx、New York、美国、10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx、New York、美国、10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn、New York、美国、11203-2098
- Children's Hospital at Downstate
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New York、New York、美国、10016
- New York University NY (5012)
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New York、New York、美国、10032
- Columbia IMPAACT CRS (4101)
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New York、New York、美国、10016
- NYU/Bellevue Hospital
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New York、New York、美国、10029
- Metropolitan Hosp Ctr (5003)
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Rochester、New York、美国、14642
- Univ of Rochester Med Ctr
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Stony Brook、New York、美国、11776
- State Univ of New York at Stony Brook (5040)
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Syracuse、New York、美国、13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham、North Carolina、美国、27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia、Pennsylvania、美国、19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis、Tennessee、美国、38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis、Tennessee、美国、38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville、Tennessee、美国、37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston、Texas、美国、77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle、Washington、美国、98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle、Washington、美国、98105
- University of Washington NICHD CRS (5029)
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Seattle、Washington、美国、98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- HIV infected
- At least 14 weeks pregnant OR have delivered a liveborn or stillborn infant and are within 14 days of the delivery
- Currently receiving care at an IMPAACT or other participating site
- Have a parent or guardian willing to provide signed informed consent, if applicable
- Mentally capable of giving informed consent to have the infant and self followed at an IMPAACT site
Exclusion Criteria:
- Intend to end the pregnancy
- Unable to come for a study visit within 14 days after delivery (if known to be HIV infected prior to delivery) OR within 28 days after delivery (if found to be HIV infected at the time of labor and delivery or within 14 days after delivery)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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1
Pregnant, HIV-infected women
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Adherence will be assessed using questionnaires at all study visits.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Maternal and infant response to prescribed interventions
大体时间：Throughout study
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Throughout study
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Immune and viral parameters of participants taking prescribed interventions
大体时间：Throughout study
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Throughout study
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
大体时间：Throughout study
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Throughout study
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Clinical, immunological, and virological responses in HIV-infected women
大体时间：Throughout study
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Throughout study
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Mother-to-child transmission rates of resistance mutations
大体时间：Throughout study
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Throughout study
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
大体时间：Throughout study
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Throughout study
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合作者和调查者
合作者
调查人员
- 学习椅：Ruth Tuomala, MD、Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- 学习椅：Gwen Scott, MD、Pediatric Infectious Diseases, University of Miami School of Medicine
出版物和有用的链接
一般刊物
- Ciambrone D, Loewenthal HG, Bazerman LB, Zorilla C, Urbina B, Mitty JA. Adherence among women with HIV infection in Puerto Rico: the potential use of modified directly observed therapy (MDOT) among pregnant and postpartum women. Women Health. 2006;44(4):61-77. doi: 10.1300/j013v44n04_04.
- Kingston MA, Letham CJ, McQuillan O. Adherence to antiretroviral therapy in pregnancy. Int J STD AIDS. 2007 Nov;18(11):787-9. doi: 10.1258/095646207782212216.
- Bardeguez AD, Lindsey JC, Shannon M, Tuomala RE, Cohn SE, Smith E, Stek A, Buschur S, Cotter A, Bettica L, Read JS; PACTG 1025 Protocol Team. Adherence to antiretrovirals among US women during and after pregnancy. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):408-17. doi: 10.1097/QAI.0b013e31817bbe80.
- Momplaisir F, Hussein M, Kacanek D, Brady K, Agwu A, Scott G, Tuomala R, Bennett D. Perinatal Depressive Symptoms, Human Immunodeficiency Virus (HIV) Suppression, and the Underlying Role of Antiretroviral Therapy Adherence: A Longitudinal Mediation Analysis in the IMPAACT P1025 Cohort. Clin Infect Dis. 2021 Oct 20;73(8):1379-1387. doi: 10.1093/cid/ciab416.
- Jao J, Kacanek D, Williams PL, Geffner ME, Livingston EG, Sperling RS, Patel K, Bardeguez AD, Burchett SK, Chakhtoura N, Scott GB, Van Dyke RB, Abrams EJ; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol. Birth Weight and Preterm Delivery Outcomes of Perinatally vs Nonperinatally Human Immunodeficiency Virus-Infected Pregnant Women in the United States: Results From the PHACS SMARTT Study and IMPAACT P1025 Protocol. Clin Infect Dis. 2017 Sep 15;65(6):982-989. doi: 10.1093/cid/cix488.
- Scott GB, Brogly SB, Muenz D, Stek AM, Read JS; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study Team. Missed Opportunities for Prevention of Mother-to-Child Transmission of Human Immunodeficiency Virus. Obstet Gynecol. 2017 Apr;129(4):621-628. doi: 10.1097/AOG.0000000000001929.
- Livingston EG, Huo Y, Patel K, Tuomala RE, Scott GB, Stek A; P1025 Team of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group. Complications and Route of Delivery in a Large Cohort Study of HIV-1-Infected Women-IMPAACT P1025. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):74-82. doi: 10.1097/QAI.0000000000001021.
- Katz IT, Leister E, Kacanek D, Hughes MD, Bardeguez A, Livingston E, Stek A, Shapiro DE, Tuomala R. Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study. Ann Intern Med. 2015 Jan 20;162(2):90-9. doi: 10.7326/M13-2005.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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