A5188: A PHASE II, PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYS

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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. A5188 is a phase II, open-label, non-randomized, multicenter PK study that will examine the interaction between a stable PI (LPV/r)-containing regimen and the ORTHO EVRA patch in HIV-1-infected women of reproductive age. The effect of LPV/r on the EE PK of single dose oral contraceptive ON 1/35 will also be studied. To determine the effect of LPV/r on EE PK with the TCS, ORTH EVRA, patch the study will monitor EE levels during patch cycle week 3 (study weeks M+3 to M+4) in women on stable LPV/r and those who are not receiving PIs, NNRTIs, or any antiretroviral (ARV) therapy. NGMN PK will be measured in both study arms during TCS cycle week 3. The study will compare plasma HIV-1 RNA levels, CD4+/CD8+ cell counts, and clinical parameters before and after the initiation of the ORTHO EVRA patch.