RANDOMIZED TRIAL OF PROTEASE INHIBITOR-INCLUDING VS PROTEASE INHIBITOR-SPARING

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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. The study is a multi-center (AIDS), ACTG randomized clinical trial involving 400 women and their pregnancies, of which 6 will be done at LAC+USC. The study design is excellent offering 3-drug combination therapy to both study groups, varying only the nevirapine and nelfinavir components. There also will be pharmacokinetic evaluations at 34 weeks and 8 weeks postpartum. The GCRC will be used to for these evaluations. Testing for gestational diabetes will also be done following standard protocol. Appropriate follow-up of the infant is also planned with opportunity for long-term enrollment into the PACTG 291G trial. The study is well written and well designed, by an experienced study group with great expertise in this area.