HIV Infections Clinical Trial
Official title:
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.
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.
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Observational Model: Case Control
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