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

A Study of HIV Levels During Pregnancy and After Childbirth

23. juli 2012 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Prospective Observational Study of Virologic and Immunologic Changes in HIV-Infected Women During the Postpartum Period

The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs have an increased amount of HIV in their blood (viral load) after having the baby.

The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir [NFV] and lopinavir/ritonavir [LPV/r]) in HIV-infected women during pregnancy and after childbirth.

Sometimes pregnant women have an increase in their HIV viral load after their baby is born. This study will try to find out how often this happens. It will also examine possible reasons why the increase in viral load occurs.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Limited data suggest that HIV-infected pregnant women develop postpartum viral rebound. However, viral load changes in the postpartum period have not been adequately characterized. Changes in adherence to antiretroviral therapy, pregnancy-related changes in pharmacokinetics of antiretroviral medications, and decline in immune competence are mechanisms by which postpartum viral load rebound may occur. This study is designed to characterize the incidence and magnitude of postpartum viral rebound during the initial 24 weeks postpartum and to explore the mechanisms and consequences of viral rebound.

Eligible patients are evaluated at gestational weeks 34 and 36, at delivery, and at regular visits for 96 weeks postpartum. Most evaluations include a medical history, physical exam, laboratory tests, and adherence and quality-of-life questionnaires. Viral load and CD4/CD8 cell counts are measured frequently.

Patients are expected to receive at least 8 weeks of stable HAART before delivery, and to continue HAART throughout the remainder of the study. The choice of HAART is left to the primary provider. No antiretroviral drugs are provided by this study.

Patients participating in the A5153s substudy receive either NFV or LPV/r as part of their HAART. Pharmacokinetic blood sampling takes place at 36 weeks gestation, 6 weeks postpartum, and 24 weeks postpartum. Patients record the administration times and doses of their NFV or LPV/r for 48 hours prior to each substudy visit, and hold their regularly scheduled doses of antiretroviral medications on substudy days. Patients arrive at the clinic fasting (no food or drink for the previous 8 hours) and are given a standardized breakfast prior to supervised administration of their NFV or LPV/r dose. An intravenous catheter is placed in an arm vein for blood collection at pre-dose and 1, 2, 4, and 6 hours post-dose.

Undersøgelsestype

Observationel

Tilmelding

129

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, 35294
        • Univ of Alabama at Birmingham
    • California
      • Los Angeles, California, Forenede Stater, 90095-1793
        • UCLA School of Medicine
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County Medical Center/USC
      • San Diego, California, Forenede Stater, 92103
        • UCSD Mother, Child & Adolescent HIV Program
      • San Francisco, California, Forenede Stater, 94110
        • San Francisco General Hosp
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32209
        • Univ of Florida- Health Science Ctr
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory Univ
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 98616-2396
        • University of Hawaii
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, Forenede Stater, 60611-3015
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hosp Core Ctr
      • Chicago, Illinois, Forenede Stater, 60614
        • Chicago Childrens Memorial Hospital (Pediatric)
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ Hosp
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Childrens Hospital of Michigan
      • Detroit, Michigan, Forenede Stater, 48201-1427
        • Hutzel Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455-0392
        • Hennepin County Med Clinic
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07103
        • Univ of Med & Dentistry of NJ/Univ Hosp
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Jacobi Med Ctr
      • New York, New York, Forenede Stater, 10032-3784
        • Columbia University
      • New York,, New York, Forenede Stater, 10016-6481
        • NYU/Bellevue
      • Stony Brook, New York, Forenede Stater, 11794-8111
        • State Univ of New York at Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Univ of North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, Forenede Stater, 44109-1998
        • MetroHealth Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-2582
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hosp / Brown Univ
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105-2794
        • The Regional Med Ctr, Memphis
      • Nashville, Tennessee, Forenede Stater, 37203
        • Comprehensive Care Clinic
    • Texas
      • Dallas, Texas, Forenede Stater, 75235-9173
        • University of Texas, Southwestern Medical Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Univ of Washington (Seattle)
  • Puerto Rico
      • San Juan, Puerto Rico
        • San Juan City Hosp

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

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

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are age 13 or older.
  • Are between 22 and 30 weeks pregnant.
  • Have had their pregnancy confirmed by ultrasound at 14 weeks gestation or later.
  • Are infected with HIV.
  • Are planning to receive at least 8 weeks of highly active antiretroviral therapy (HAART) by the time they have their baby.
  • Are available for follow-up for the duration of the study.

Exclusion Criteria

Patients may not be eligible for this study if they:

  • Intend to terminate their pregnancy.
  • Intend to breast-feed their baby.
  • Are carrying a baby with major abnormalities, including spina bifida, anencephaly, hydrops, or ascites.
  • Have taken certain medications.
  • Are enrolled in other studies that require large blood draws.
  • Will be taking anti-HIV drugs only to prevent mother-to-child transmission of HIV, and not to treat the maternal infection itself.
  • Actively abuse drugs or alcohol in a way that would interfere with participation in the study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Beverly Sha
  • Studiestol: Alice Stek

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.

Datoer for studieregistrering

Først indsendt

19. juli 2002

Først indsendt, der opfyldte QC-kriterier

19. juli 2002

Først opslået (Skøn)

22. juli 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTG A5150
  • ACTG A5153s
  • AACTG A5150
  • AACTG A5153s

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner