- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00017797
Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione
Contatti e Sedi
Luoghi di studio
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San Juan, Porto Rico, 009367344
- San Juan City Hosp
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- Univ of Alabama at Birmingham - Pediatric
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California
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Los Angeles, California, Stati Uniti, 90033
- Los Angeles County - USC Med Ctr
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06504
- Yale University School of Medicine
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20060
- Howard Univ Hosp
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Florida
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Jacksonville, Florida, Stati Uniti, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Stati Uniti, 33161
- Univ of Miami (Pediatric)
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Georgia
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Columbus, Georgia, Stati Uniti, 31901
- The Med Ctr Inc
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96816-2396
- Univ of Hawaii
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- The CORE Ctr
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Chicago, Illinois, Stati Uniti, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, Stati Uniti, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Indiana
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Indianapolis, Indiana, Stati Uniti, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, Stati Uniti, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, Stati Uniti, 46202
- Wishard Hosp
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Maryland
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Baltimore, Maryland, Stati Uniti, 20201
- Univ of Marlyand (Pediatric)
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Brigham and Womens Hosp
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Stati Uniti, 016550001
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Stati Uniti, 48201
- Children's Hosp of Michigan
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Detroit, Michigan, Stati Uniti, 48201-1427
- Hutzel Hospital
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455-0392
- Univ of Minnesota
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Minneapolis, Minnesota, Stati Uniti, 554145
- Hennepin County Med Ctr
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Missouri
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St.Louis, Missouri, Stati Uniti, 63108-2138
- Washington Univ (St.Louis)
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New Jersey
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New Brunswick, New Jersey, Stati Uniti, 08903
- St Peter's Med Ctr
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Newark, New Jersey, Stati Uniti, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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Bronx, New York, Stati Uniti, 10016
- Jacobi Med Ctr
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New York, New York, Stati Uniti, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Stati Uniti, 10029
- Metropolitan Hosp Ctr
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Rochester, New York, Stati Uniti, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- Univ of North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke Univ Med Ctr
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Ohio
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Cincinnati, Ohio, Stati Uniti, 452670405
- Univ of Cincinnati
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Cleveland, Ohio, Stati Uniti, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, Stati Uniti, 441091998
- MetroHealth Med Ctr
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Univ of Pittsburgh
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Tennessee
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Memphis, Tennessee, Stati Uniti, 381052794
- Saint Jude Children's Research Hosp of Memphis
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Nashville, Tennessee, Stati Uniti, 37203
- Vanderbilt Univ Med Ctr
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Univ of Washington
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Seattle, Washington, Stati Uniti, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Elizabeth Livingston
Pubblicazioni e link utili
Studiare le date dei record
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- ACTG A5084
- AACTG A5084
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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