- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00028145
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile, Alabama, Estados Unidos, 36688
- University of South Alabama
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Phoenix Childrens Hospital
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California
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Long Beach, California, Estados Unidos, 90801
- Long Beach Memorial (Pediatric)
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Long Beach, California, Estados Unidos, 90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles, California, Estados Unidos, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Estados Unidos, 90033
- Usc La Nichd Crs (5048)
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Los Angeles, California, Estados Unidos, 90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles, California, Estados Unidos, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Estados Unidos, 92103
- Univ of California, San Diego (4601)
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San Francisco, California, Estados Unidos, 94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance, California, Estados Unidos, 90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver, Colorado, Estados Unidos, 80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington, Connecticut, Estados Unidos, 06030-3805
- University of Connecticut, Farmington
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New Haven, Connecticut, Estados Unidos, 06504
- Yale Univ School of Med
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington, District of Columbia, Estados Unidos, 200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington, District of Columbia, Estados Unidos, 20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33311
- North Broward Hosp District
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Ft Lauderdal, Florida, Estados Unidos, 33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville, Florida, Estados Unidos, 32209
- University of Florida Jacksonville (5051)
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Miami, Florida, Estados Unidos, 33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami, Florida, Estados Unidos, 33136
- Jackson Memorial Hosp
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St Petersburg, Florida, Estados Unidos, 33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta, Georgia, Estados Unidos, 30912
- Med College of Georgia
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Columbus, Georgia, Estados Unidos, 31901
- The Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Cook County Hospital
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Chicago, Illinois, Estados Unidos, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago, Illinois, Estados Unidos, 60608-1797
- Womens & Childrens HIV Program
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Chicago, Illinois, Estados Unidos, 60612-7234
- Univ of Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago, Illinois, Estados Unidos, 60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112-2699
- Tulane University New Orleans (5095)
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New Orleans, Louisiana, Estados Unidos, 70112-2699
- Tulane-Lakeside Hospital
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Med Ctr (Pediatric) (5011)
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Boston, Massachusetts, Estados Unidos, 02478
- Brigham and Women's Hosp
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Estados Unidos, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester, Massachusetts, Estados Unidos, 01655
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-1427
- Hutzel Hospital (5089)
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis, Missouri, Estados Unidos, 63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark, New Jersey, Estados Unidos, 07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark, New Jersey, Estados Unidos, 07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark, New Jersey, Estados Unidos, 07103
- New Jersey Medical School (2802)
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New York
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Bronx, New York, Estados Unidos, 19461
- Montefiore Medical / AECOM
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Bronx, New York, Estados Unidos, 10451
- Lincoln Medical & Mental Health Center
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Bronx, New York, Estados Unidos, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx, New York, Estados Unidos, 10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn, New York, Estados Unidos, 11203-2098
- Children's Hospital at Downstate
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New York, New York, Estados Unidos, 10016
- New York University NY (5012)
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New York, New York, Estados Unidos, 10032
- Columbia IMPAACT CRS (4101)
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New York, New York, Estados Unidos, 10016
- NYU/Bellevue Hospital
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New York, New York, Estados Unidos, 10029
- Metropolitan Hosp Ctr (5003)
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Rochester, New York, Estados Unidos, 14642
- Univ of Rochester Med Ctr
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Stony Brook, New York, Estados Unidos, 11776
- State Univ of New York at Stony Brook (5040)
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia, Pennsylvania, Estados Unidos, 19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis, Tennessee, Estados Unidos, 38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle, Washington, Estados Unidos, 98105
- University of Washington NICHD CRS (5029)
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Seattle, Washington, Estados Unidos, 98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico Pediatric HIV/AIDS (6601)
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San Juan, Puerto Rico, 00936-7344
- San Juan City Hosp. PR NICHD CRS (5031)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Maternal and infant response to prescribed interventions
Periodo de tiempo: Throughout study
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Throughout study
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Immune and viral parameters of participants taking prescribed interventions
Periodo de tiempo: Throughout study
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Throughout study
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Periodo de tiempo: Throughout study
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Throughout study
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Clinical, immunological, and virological responses in HIV-infected women
Periodo de tiempo: Throughout study
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Throughout study
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Mother-to-child transmission rates of resistance mutations
Periodo de tiempo: Throughout study
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Throughout study
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Periodo de tiempo: Throughout study
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Throughout study
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- Silla de estudio: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PACTG P1025
- U01AI068632 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre Adherence assessment
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Centre Francois BaclesseTerminado
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