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

Completed

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00017797

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

160

Last updated by the study team

2006-08-07

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• The Med Ctr Inc — Columbus, Georgia, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Mt Sinai Hosp Med Ctr / Dept of Pediatrics — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Univ of Marlyand (Pediatric) — Baltimore, Maryland, United States
• Brigham and Womens Hosp — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Hutzel Hospital — Detroit, Michigan, United States
• Children's Hosp of Michigan — Detroit, Michigan, United States
• Hennepin County Med Ctr — Minneapolis, Minnesota, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Washington Univ (St.Louis) — St Louis, Missouri, United States
• St Peter's Med Ctr — New Brunswick, New Jersey, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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