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Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women

3 augustus 2006 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women

The purpose of this study is to find out if HIV-infected pregnant women who take protease inhibitors (PIs) are more likely to have blood sugar problems than those who do not take PIs.

HIV-infected people generally are treated with a combination of different types of anti-HIV drugs, 1 of which is usually a PI. The same holds true for pregnant women, but not much is known about the use of these drugs in pregnancy. Blood sugar and liver problems caused by anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not. Also, certain physical changes brought about by pregnancy may affect the way drugs are handled in the body. There remains a need for further study into the use of anti-HIV drugs during pregnancy and their effect on the safety of the mother and baby.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

The dramatic impact of potent combination antiretroviral therapies on the course of HIV disease has made the use of PIs routine in the care of HIV-1-infected individuals. Combination therapy likewise has become the standard of care in pregnant individuals, even though information on use of these drugs during human pregnancy is limited. There are no published prospective evaluations of toxicities experienced by pregnant women on PI-containing antiretroviral regimens, despite findings of metabolic disturbances of glucose, fatty acids, and cholesterol, as well as lactic acidosis/hepatic steatosis in nonpregnant individuals treated with antiretrovirals. Gastrointestinal (GI) side effects also are well documented in nonpregnant individuals treated with PIs, but have not been systematically evaluated in pregnancy. In addition, the physiologic changes brought about by pregnancy may influence the pharmacokinetics, safety, and side effects of antiretroviral drugs. There remains a need for further evaluation of the use of antiretrovirals during pregnancy and their impact on maternal, fetal, and infant safety.

Patients are stratified according to whether or not they are on a PI-containing antiretroviral regimen and the number of weeks of gestation (26 weeks or less versus greater than 26 weeks). Patients are followed at 8-week intervals from the time of entry until delivery or pregnancy termination, with an additional visit at 12 weeks after delivery or pregnancy termination. All infants born to study participants are evaluated at the time of delivery (anthropometrics and HIV DNA PCR) and are seen again at the mothers' 12-week post-delivery visit. Glucose tolerance testing and other metabolic studies are performed serially during pregnancy and again postpartum. This is an observational study and drugs are not supplied. Patients receiving antiretroviral therapy must obtain their own medications.

Studietype

Observationeel

Inschrijving

160

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Puerto Rico
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Univ of Alabama at Birmingham - Pediatric
    • California
      • Los Angeles, California, Verenigde Staten, 90033
        • Los Angeles County - USC Med Ctr
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06504
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20060
        • Howard Univ Hosp
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, Verenigde Staten, 33161
        • Univ of Miami (Pediatric)
    • Georgia
      • Columbus, Georgia, Verenigde Staten, 31901
        • The Med Ctr Inc
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96816-2396
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • The CORE Ctr
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, Verenigde Staten, 60608
        • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 462025250
        • Indiana Univ Hosp
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Methodist Hosp of Indiana / Life Care Clinic
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Wishard Hosp
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 20201
        • Univ of Marlyand (Pediatric)
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Brigham and Womens Hosp
      • Springfield, Massachusetts, Verenigde Staten, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, Verenigde Staten, 016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Children's Hosp of Michigan
      • Detroit, Michigan, Verenigde Staten, 48201-1427
        • Hutzel Hospital
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455-0392
        • Univ of Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 554145
        • Hennepin County Med Ctr
    • Missouri
      • St.Louis, Missouri, Verenigde Staten, 63108-2138
        • Washington Univ (St.Louis)
    • New Jersey
      • New Brunswick, New Jersey, Verenigde Staten, 08903
        • St Peter's Med Ctr
      • Newark, New Jersey, Verenigde Staten, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
    • New York
      • Bronx, New York, Verenigde Staten, 10016
        • Jacobi Med Ctr
      • New York, New York, Verenigde Staten, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Verenigde Staten, 10029
        • Metropolitan Hosp Ctr
      • Rochester, New York, Verenigde Staten, 14642
        • Univ of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • Univ of North Carolina
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 452670405
        • Univ of Cincinnati
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, Verenigde Staten, 441091998
        • MetroHealth Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • Univ of Pittsburgh
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 381052794
        • Saint Jude Children's Research Hosp of Memphis
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Vanderbilt Univ Med Ctr
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Univ of Washington
      • Seattle, Washington, Verenigde Staten, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are female and 13 years of age or older.
  • Are between 20 and 34 weeks pregnant at study entry.
  • Had an ultrasound performed at 16 or more weeks of pregnancy.
  • Have consent of a parent or guardian if under 18 years of age. The father of the baby, if available, also must give consent.
  • Have taken the same anti-HIV drugs, including a PI, during the 8 weeks just before study entry. If not taking a PI or any anti-HIV drug, must not have taken a PI during the 8 weeks just before study entry. Patients must carry on this way for the entire study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have diabetes. Patients who have had diabetes caused by pancreas problems or steroid use in the past, but now have normal blood sugar without having to take drugs or special diets, are allowed. Patients who have had blood sugar problems in a past pregnancy also are allowed.
  • Had a serious infection or medical condition within 30 days before study entry.
  • Are enrolled in another study which requires a lot of blood tests.
  • Take, or have taken in the 6 weeks before study entry, any of the following drugs: hormones (growth hormone, testosterone, or steroids), thalidomide, interleukins or interferons, efavirenz, hydroxyurea, drugs to control blood sugar, and anti-cancer drugs.
  • Take, or have taken in the year before study entry, steroids, e.g., prednisone, for more than 14 days in any 3-month period. Inhaled steroids and steroid creams/ointments are allowed.
  • Take, or have taken in the 30 days before study entry, PIs with lovastatin or simvastatin (2 drugs that lower the amount of fat in the blood).
  • Have an ultrasound showing a major abnormality in the baby.
  • Have problems with their pregnancy and/or are expecting more than 1 baby.
  • Abuse drugs or alcohol.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Onderzoekers

  • Studie stoel: Elizabeth Livingston

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Studieregistratiedata

Eerst ingediend

12 juni 2001

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2001

Eerst geplaatst (Schatting)

31 augustus 2001

Updates van studierecords

Laatste update geplaatst (Schatting)

7 augustus 2006

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2006

Laatst geverifieerd

1 augustus 2006

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ACTG A5084
  • AACTG A5084

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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