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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile、Alabama、アメリカ、36688
- University of South Alabama
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Arizona
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Phoenix、Arizona、アメリカ、85006
- Phoenix Childrens Hospital
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California
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Long Beach、California、アメリカ、90801
- Long Beach Memorial (Pediatric)
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Long Beach、California、アメリカ、90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles、California、アメリカ、900951752
- UCLA Med Ctr / Pediatric
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Los Angeles、California、アメリカ、90033
- Usc La Nichd Crs (5048)
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Los Angeles、California、アメリカ、90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles、California、アメリカ、90033
- Los Angeles County Medical Center/USC
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San Diego、California、アメリカ、92103
- Univ of California, San Diego (4601)
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San Francisco、California、アメリカ、94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance、California、アメリカ、90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver、Colorado、アメリカ、80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington、Connecticut、アメリカ、06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington、Connecticut、アメリカ、06030-3805
- University of Connecticut, Farmington
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New Haven、Connecticut、アメリカ、06504
- Yale Univ School of Med
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District of Columbia
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Washington、District of Columbia、アメリカ、20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington、District of Columbia、アメリカ、200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington、District of Columbia、アメリカ、20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale、Florida、アメリカ、33311
- North Broward Hosp District
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Ft Lauderdal、Florida、アメリカ、33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville、Florida、アメリカ、32209
- University of Florida Jacksonville (5051)
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Miami、Florida、アメリカ、33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami、Florida、アメリカ、33136
- Jackson Memorial Hosp
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St Petersburg、Florida、アメリカ、33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta、Georgia、アメリカ、30912
- Med College of Georgia
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Columbus、Georgia、アメリカ、31901
- The Medical Center
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Illinois
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Chicago、Illinois、アメリカ、60612
- Cook County Hospital
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Chicago、Illinois、アメリカ、60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago、Illinois、アメリカ、60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago、Illinois、アメリカ、60608-1797
- Womens & Childrens HIV Program
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Chicago、Illinois、アメリカ、60612-7234
- Univ of Illinois
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Chicago、Illinois、アメリカ、60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago、Illinois、アメリカ、60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans、Louisiana、アメリカ、70112-2699
- Tulane University New Orleans (5095)
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New Orleans、Louisiana、アメリカ、70112-2699
- Tulane-Lakeside Hospital
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New Orleans、Louisiana、アメリカ、70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore、Maryland、アメリカ、21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston、Massachusetts、アメリカ、02118
- Boston Med Ctr (Pediatric) (5011)
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Boston、Massachusetts、アメリカ、02478
- Brigham and Women's Hosp
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Springfield、Massachusetts、アメリカ、01199
- Baystate Med Ctr of Springfield
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Worcester、Massachusetts、アメリカ、01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester、Massachusetts、アメリカ、01655
- Univ of Massachusetts Med School
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Michigan
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Detroit、Michigan、アメリカ、48201-1427
- Hutzel Hospital (5089)
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Detroit、Michigan、アメリカ、48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis、Missouri、アメリカ、63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark、New Jersey、アメリカ、07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark、New Jersey、アメリカ、07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark、New Jersey、アメリカ、07103
- New Jersey Medical School (2802)
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New York
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Bronx、New York、アメリカ、19461
- Montefiore Medical / AECOM
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Bronx、New York、アメリカ、10451
- Lincoln Medical & Mental Health Center
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Bronx、New York、アメリカ、10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx、New York、アメリカ、10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn、New York、アメリカ、11203-2098
- Children's Hospital at Downstate
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New York、New York、アメリカ、10016
- New York University NY (5012)
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New York、New York、アメリカ、10032
- Columbia IMPAACT CRS (4101)
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New York、New York、アメリカ、10016
- NYU/Bellevue Hospital
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New York、New York、アメリカ、10029
- Metropolitan Hosp Ctr (5003)
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Rochester、New York、アメリカ、14642
- Univ of Rochester Med Ctr
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Stony Brook、New York、アメリカ、11776
- State Univ of New York at Stony Brook (5040)
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Syracuse、New York、アメリカ、13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Hospital of the University of Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia、Pennsylvania、アメリカ、19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis、Tennessee、アメリカ、38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston、Texas、アメリカ、77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle、Washington、アメリカ、98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle、Washington、アメリカ、98105
- University of Washington NICHD CRS (5029)
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Seattle、Washington、アメリカ、98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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San Juan、プエルトリコ、00936-5067
- University of Puerto Rico Pediatric HIV/AIDS (6601)
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San Juan、プエルトリコ、00936-7344
- San Juan City Hosp. PR NICHD CRS (5031)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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1
Pregnant, HIV-infected women
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Adherence will be assessed using questionnaires at all study visits.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Maternal and infant response to prescribed interventions
時間枠：Throughout study
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Throughout study
|
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Immune and viral parameters of participants taking prescribed interventions
時間枠：Throughout study
|
Throughout study
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
時間枠：Throughout study
|
Throughout study
|
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Clinical, immunological, and virological responses in HIV-infected women
時間枠：Throughout study
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Throughout study
|
|
Mother-to-child transmission rates of resistance mutations
時間枠：Throughout study
|
Throughout study
|
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
時間枠：Throughout study
|
Throughout study
|
協力者と研究者
協力者
捜査官
- スタディチェア：Ruth Tuomala, MD、Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- スタディチェア：Gwen Scott, MD、Pediatric Infectious Diseases, University of Miami School of Medicine
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。