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
2 other identifiers
observational
160
2 countries
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
40 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 7, 2006
August 1, 2006
June 12, 2001
August 3, 2006
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Yale University School of Medicine
New Haven, Connecticut, 06504, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
The Med Ctr Inc
Columbus, Georgia, 31901, United States
Univ of Hawaii
Honolulu, Hawaii, 96816-2396, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Univ of Marlyand (Pediatric)
Baltimore, Maryland, 20201, United States
Brigham and Womens Hosp
Boston, Massachusetts, 02215, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Hutzel Hospital
Detroit, Michigan, 48201-1427, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Hennepin County Med Ctr
Minneapolis, Minnesota, 554145, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392, United States
Washington Univ (St.Louis)
St Louis, Missouri, 63108-2138, United States
St Peter's Med Ctr
New Brunswick, New Jersey, 08903, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Jacobi Med Ctr
The Bronx, New York, 10016, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Washington
Seattle, Washington, 98104, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371, United States
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (1)
Livingston EG, Cohn SE, Yang Y, Watts HD, Bardeguez AD, Jones TB, Smith LM, Umbleja T, McComsey GA. Lipids and lactate in human immunodeficiency virus-1 infected pregnancies with or without protease inhibitor-based therapy. Obstet Gynecol. 2007 Aug;110(2 Pt 1):391-7. doi: 10.1097/01.AOG.0000271210.79340.4c.
PMID: 17666616DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elizabeth Livingston