A5188: A PHASE II, PHARMACOKINECTIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYST

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: Due to the presumed avoidance of the first-pass effect and metabolism by gut cytochrome enzymes in HIV-1 infected women of reproductive age, it is hypothesized that there will be no difference in EE area under the concentration-time curve (AUC) at transdermal contraception week 3 (study weeks M+3 to M+4) between women on stable LPV/r and those not on PIs or NNRTIs or on any ARV therapy. Primary Objectivs: To evaluate the effect of LPV/r on the PK of EE in HIV-1-infected women of reproductive age by comparing the EE AUC during ORTHO EVRA¿¿ transdermal contraceptive patch week 3 (study weeks M+3 to M+4) in women on LPV/r with the EE AUC measured in women who are not receiving PIs, NNRTIs, or any ARV therapy.