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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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San Juan, Portoryko, 00936-5067
- University of Puerto Rico Pediatric HIV/AIDS (6601)
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San Juan, Portoryko, 00936-7344
- San Juan City Hosp. PR NICHD CRS (5031)
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-
-
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile, Alabama, Stany Zjednoczone, 36688
- University of South Alabama
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Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 85006
- Phoenix Childrens Hospital
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California
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Long Beach, California, Stany Zjednoczone, 90801
- Long Beach Memorial (Pediatric)
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Long Beach, California, Stany Zjednoczone, 90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles, California, Stany Zjednoczone, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Stany Zjednoczone, 90033
- Usc La Nichd Crs (5048)
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Los Angeles, California, Stany Zjednoczone, 90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles, California, Stany Zjednoczone, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Stany Zjednoczone, 92103
- Univ of California, San Diego (4601)
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San Francisco, California, Stany Zjednoczone, 94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance, California, Stany Zjednoczone, 90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington, Connecticut, Stany Zjednoczone, 06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington, Connecticut, Stany Zjednoczone, 06030-3805
- University of Connecticut, Farmington
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New Haven, Connecticut, Stany Zjednoczone, 06504
- Yale Univ School of Med
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District of Columbia
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Washington, District of Columbia, Stany Zjednoczone, 20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington, District of Columbia, Stany Zjednoczone, 200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington, District of Columbia, Stany Zjednoczone, 20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale, Florida, Stany Zjednoczone, 33311
- North Broward Hosp District
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Ft Lauderdal, Florida, Stany Zjednoczone, 33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville, Florida, Stany Zjednoczone, 32209
- University of Florida Jacksonville (5051)
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Miami, Florida, Stany Zjednoczone, 33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami, Florida, Stany Zjednoczone, 33136
- Jackson Memorial Hosp
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St Petersburg, Florida, Stany Zjednoczone, 33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta, Georgia, Stany Zjednoczone, 30912
- Med College of Georgia
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Columbus, Georgia, Stany Zjednoczone, 31901
- The Medical Center
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- Cook County Hospital
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Chicago, Illinois, Stany Zjednoczone, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago, Illinois, Stany Zjednoczone, 60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago, Illinois, Stany Zjednoczone, 60608-1797
- Womens & Childrens HIV Program
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Chicago, Illinois, Stany Zjednoczone, 60612-7234
- Univ of Illinois
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Chicago, Illinois, Stany Zjednoczone, 60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago, Illinois, Stany Zjednoczone, 60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70112-2699
- Tulane University New Orleans (5095)
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New Orleans, Louisiana, Stany Zjednoczone, 70112-2699
- Tulane-Lakeside Hospital
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore, Maryland, Stany Zjednoczone, 21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston, Massachusetts, Stany Zjednoczone, 02118
- Boston Med Ctr (Pediatric) (5011)
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Boston, Massachusetts, Stany Zjednoczone, 02478
- Brigham and Women's Hosp
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Springfield, Massachusetts, Stany Zjednoczone, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Stany Zjednoczone, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester, Massachusetts, Stany Zjednoczone, 01655
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201-1427
- Hutzel Hospital (5089)
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Detroit, Michigan, Stany Zjednoczone, 48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis, Missouri, Stany Zjednoczone, 63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark, New Jersey, Stany Zjednoczone, 07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark, New Jersey, Stany Zjednoczone, 07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark, New Jersey, Stany Zjednoczone, 07103
- New Jersey Medical School (2802)
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New York
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Bronx, New York, Stany Zjednoczone, 19461
- Montefiore Medical / AECOM
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Bronx, New York, Stany Zjednoczone, 10451
- Lincoln Medical & Mental Health Center
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Bronx, New York, Stany Zjednoczone, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx, New York, Stany Zjednoczone, 10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn, New York, Stany Zjednoczone, 11203-2098
- Children's Hospital at Downstate
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New York, New York, Stany Zjednoczone, 10016
- New York University NY (5012)
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New York, New York, Stany Zjednoczone, 10032
- Columbia IMPAACT CRS (4101)
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New York, New York, Stany Zjednoczone, 10016
- NYU/Bellevue Hospital
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New York, New York, Stany Zjednoczone, 10029
- Metropolitan Hosp Ctr (5003)
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Rochester, New York, Stany Zjednoczone, 14642
- Univ of Rochester Med Ctr
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Stony Brook, New York, Stany Zjednoczone, 11776
- State Univ of New York at Stony Brook (5040)
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Syracuse, New York, Stany Zjednoczone, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis, Tennessee, Stany Zjednoczone, 38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston, Texas, Stany Zjednoczone, 77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle, Washington, Stany Zjednoczone, 98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle, Washington, Stany Zjednoczone, 98105
- University of Washington NICHD CRS (5029)
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Seattle, Washington, Stany Zjednoczone, 98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
1
Pregnant, HIV-infected women
|
Adherence will be assessed using questionnaires at all study visits.
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Maternal and infant response to prescribed interventions
Ramy czasowe: Throughout study
|
Throughout study
|
|
Immune and viral parameters of participants taking prescribed interventions
Ramy czasowe: Throughout study
|
Throughout study
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Ramy czasowe: Throughout study
|
Throughout study
|
|
Clinical, immunological, and virological responses in HIV-infected women
Ramy czasowe: Throughout study
|
Throughout study
|
|
Mother-to-child transmission rates of resistance mutations
Ramy czasowe: Throughout study
|
Throughout study
|
|
Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Ramy czasowe: Throughout study
|
Throughout study
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Krzesło do nauki: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- Krzesło do nauki: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- PACTG P1025
- U01AI068632 (Grant/umowa NIH USA)
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