3 Clinical Trials for Various Conditions
The objectives of this application are to provide mechanistic understanding of altered drug metabolism by hepatic cytochrome CYP3A4 and to translate the findings to human pregnancy. A drug metabolized by CYP3A4, Quetiapine, will be the drug of choice mechanism to understand the enzyme's induction. Pregnant women currently on Quetiapine will be recruited. If the women enroll, the women will participate in four pharmacokinetic (PK) studies (one per trimester, and one postpartum).
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.
The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies. Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.