- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 009367344
- San Juan City Hosp
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Alabama
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Birmingham, Alabama, United States, 35233
- Univ of Alabama at Birmingham - Pediatric
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California
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale University School of Medicine
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District of Columbia
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Washington, District of Columbia, United States, 20060
- Howard Univ Hosp
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Florida
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Jacksonville, Florida, United States, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, United States, 33161
- Univ of Miami (Pediatric)
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Georgia
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Columbus, Georgia, United States, 31901
- The Med Ctr Inc
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Hawaii
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Honolulu, Hawaii, United States, 96816-2396
- Univ of Hawaii
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Illinois
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Chicago, Illinois, United States, 60612
- The CORE Ctr
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, United States, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Indiana
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Indianapolis, Indiana, United States, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, United States, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, United States, 46202
- Wishard Hosp
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Maryland
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Baltimore, Maryland, United States, 20201
- Univ of Marlyand (Pediatric)
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Brigham and Womens Hosp
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Springfield, Massachusetts, United States, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, United States, 016550001
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, United States, 48201
- Children's Hosp of Michigan
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Detroit, Michigan, United States, 48201-1427
- Hutzel Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455-0392
- Univ of Minnesota
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Minneapolis, Minnesota, United States, 554145
- Hennepin County Med Ctr
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Missouri
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St.Louis, Missouri, United States, 63108-2138
- Washington Univ (St.Louis)
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- St Peter's Med Ctr
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Newark, New Jersey, United States, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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Bronx, New York, United States, 10016
- Jacobi Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10029
- Metropolitan Hosp Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Univ of North Carolina
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Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr
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Ohio
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Cincinnati, Ohio, United States, 452670405
- Univ of Cincinnati
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Cleveland, Ohio, United States, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, United States, 441091998
- MetroHealth Med Ctr
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Univ of Pittsburgh
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Tennessee
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Memphis, Tennessee, United States, 381052794
- Saint Jude Children's Research Hosp of Memphis
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Nashville, Tennessee, United States, 37203
- Vanderbilt Univ Med Ctr
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Washington
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Seattle, Washington, United States, 98104
- Univ of Washington
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Seattle, Washington, United States, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Elizabeth Livingston
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG A5084
- AACTG A5084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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