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

8 ottobre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

3090

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

14 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Primary care clinics

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
1
Pregnant, HIV-infected women
Comportamentale: Adherence assessment
Adherence will be assessed using questionnaires at all study visits.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Maternal and infant response to prescribed interventions
Lasso di tempo: Throughout study
Throughout study
Immune and viral parameters of participants taking prescribed interventions
Lasso di tempo: Throughout study
Throughout study

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2002

Completamento primario (Effettivo)

1 giugno 2013

Completamento dello studio (Effettivo)

1 giugno 2013

Date di iscrizione allo studio

Primo inviato

13 dicembre 2001

Primo inviato che soddisfa i criteri di controllo qualità

13 dicembre 2001

Primo Inserito (Stima)

14 dicembre 2001

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 ottobre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 ottobre 2014

Ultimo verificato

1 ottobre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PACTG P1025
  • U01AI068632 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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