Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

8. oktober 2014 opdateret af: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3090

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Univ. of Alabama Birmingham NICHD CRS (5096)
      • Mobile, Alabama, Forenede Stater, 36688
        • University of South Alabama
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Phoenix Childrens Hospital
    • California
      • Long Beach, California, Forenede Stater, 90801
        • Long Beach Memorial (Pediatric)
      • Long Beach, California, Forenede Stater, 90806
        • Miller Children's Hospital Long Beach (5093)
      • Los Angeles, California, Forenede Stater, 900951752
        • UCLA Med Ctr / Pediatric
      • Los Angeles, California, Forenede Stater, 90033
        • Usc La Nichd Crs (5048)
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County Medical Center/USC
      • San Diego, California, Forenede Stater, 92103
        • Univ of California, San Diego (4601)
      • San Francisco, California, Forenede Stater, 94117
        • Univ. of California San Francisco NICHD CRS (5091)
      • Torrance, California, Forenede Stater, 90509
        • Harbor-UCLA Med Ctr (5045)
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218-1088
        • University of Colorado Denver NICHD CRS (5052)
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030-3805
        • Connecticut Childrens Medical Center (Pediatric)
      • Farmington, Connecticut, Forenede Stater, 06030-3805
        • University of Connecticut, Farmington
      • New Haven, Connecticut, Forenede Stater, 06504
        • Yale Univ School of Med
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010-2970
        • Children's National Medical Center Washington DC NICHD CRS (5015)
      • Washington, District of Columbia, Forenede Stater, 200102931
        • Washington Hospital Center NICHD CRS (5023)
      • Washington, District of Columbia, Forenede Stater, 20060
        • Howard Univ Hosp (5044)
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33311
        • North Broward Hosp District
      • Ft Lauderdal, Florida, Forenede Stater, 33316
        • South Florida CDC Ft Lauderdale NICHD CRS (5055)
      • Jacksonville, Florida, Forenede Stater, 32209
        • University of Florida Jacksonville (5051)
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Pediatric/Perinatal HIV/AIDS (4201)
      • Miami, Florida, Forenede Stater, 33136
        • Jackson Memorial Hosp
      • St Petersburg, Florida, Forenede Stater, 33701
        • University of South Florida at Tampa (5018)
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Med College of Georgia
      • Columbus, Georgia, Forenede Stater, 31901
        • The Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hospital
      • Chicago, Illinois, Forenede Stater, 60608
        • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Cook County Hospital NICHD CRS (5083)
      • Chicago, Illinois, Forenede Stater, 60608-1797
        • Womens & Childrens HIV Program
      • Chicago, Illinois, Forenede Stater, 60612-7234
        • Univ of Illinois
      • Chicago, Illinois, Forenede Stater, 60614
        • Chicago Childrens Memorial Hosp (Pediatric)
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • Univ of Chicago Children's Hosp (4001)
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112-2699
        • Tulane University New Orleans (5095)
      • New Orleans, Louisiana, Forenede Stater, 70112-2699
        • Tulane-Lakeside Hospital
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University Charity Hosp of New Orleans (7201)
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University NICHD CRS (5092)
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Baltimore NICHD CRS (5094)
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children's Hospital of Boston NICHD CRS (5009)
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Med Ctr (Pediatric) (5011)
      • Boston, Massachusetts, Forenede Stater, 02478
        • Brigham and Women's Hosp
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, Forenede Stater, 01605
        • WNE Maternal Pediatric Adolescent AIDS CRS (7301)
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201-1427
        • Hutzel Hospital (5089)
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University Detroit Children's Hosp of Michigan (5041)
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63108-2138
        • St. Louis Children's Hosp
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07103
        • Univ of Med & Dentistry of New Jersey/Univ Hosp
      • Newark, New Jersey, Forenede Stater, 07103-2714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
      • Newark, New Jersey, Forenede Stater, 07103
        • New Jersey Medical School (2802)
    • New York
      • Bronx, New York, Forenede Stater, 19461
        • Montefiore Medical / AECOM
      • Bronx, New York, Forenede Stater, 10451
        • Lincoln Medical & Mental Health Center
      • Bronx, New York, Forenede Stater, 10461
        • Jacobi Med. Ctr. Bronx NICHD CRS (5013)
      • Bronx, New York, Forenede Stater, 10457
        • Bronx-Lebanon Hospital IMPAACT (6901)
      • Brooklyn, New York, Forenede Stater, 11203-2098
        • Children's Hospital at Downstate
      • New York, New York, Forenede Stater, 10016
        • New York University NY (5012)
      • New York, New York, Forenede Stater, 10032
        • Columbia IMPAACT CRS (4101)
      • New York, New York, Forenede Stater, 10016
        • NYU/Bellevue Hospital
      • New York, New York, Forenede Stater, 10029
        • Metropolitan Hosp Ctr (5003)
      • Rochester, New York, Forenede Stater, 14642
        • Univ of Rochester Med Ctr
      • Stony Brook, New York, Forenede Stater, 11776
        • State Univ of New York at Stony Brook (5040)
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical Univ
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke Univ (Pediatric) (DUMC) (4701)
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of The University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19102-1192
        • Hahnemann University Hospital (6706)
      • Philadelphia, Pennsylvania, Forenede Stater, 19134
        • The Children's Hospital of Philadelphia (6701)
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • St. Jude Childrens Research Hosp, Memphis (6501)
      • Memphis, Tennessee, Forenede Stater, 38105-2794
        • The Regional Med Ctr, Memphis (6502)
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt Univ Med Ctr
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Texas Children's Hosp / Baylor Univ (3801)
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Harborview Medical Center NICHD CRS (5027)
      • Seattle, Washington, Forenede Stater, 98105
        • University of Washington NICHD CRS (5029)
      • Seattle, Washington, Forenede Stater, 98105-0371
        • Univ of Washington Children's Hospital Seattle (5017)
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico Pediatric HIV/AIDS (6601)
      • San Juan, Puerto Rico, 00936-7344
        • San Juan City Hosp. PR NICHD CRS (5031)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Primary care clinics

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
Pregnant, HIV-infected women
Adfærdsmæssigt: Adherence assessment
Adherence will be assessed using questionnaires at all study visits.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Maternal and infant response to prescribed interventions
Tidsramme: Throughout study
Throughout study
Immune and viral parameters of participants taking prescribed interventions
Tidsramme: Throughout study
Throughout study

Sekundære resultatmål

Resultatmål
Tidsramme
Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Tidsramme: Throughout study
Throughout study
Clinical, immunological, and virological responses in HIV-infected women
Tidsramme: Throughout study
Throughout study
Mother-to-child transmission rates of resistance mutations
Tidsramme: Throughout study
Throughout study
Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Tidsramme: Throughout study
Throughout study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Studiestol: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital
  • Studiestol: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2002

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

13. december 2001

Først indsendt, der opfyldte QC-kriterier

13. december 2001

Først opslået (Skøn)

14. december 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PACTG P1025
  • U01AI068632 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Adherence assessment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner