CLINICAL TRIAL: A PHASE IV, RANDOMIZED, OPEN-LABEL STUDY OF THE TOLERABILITY OF

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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 Once daily lopinavir/ritonavir (LPV/r) liquid will be better tolerated than once daily LPV/r capsules. Primary Objectives To compare the tolerability of once daily LPV/r (800/200 mg) as 10 ml liquid vs. 6 capsules Secondary Objectives 1 To compare at week 4, or at the time therapy is discontinued, for each of the two 4 week Steps of the cross-over trial (Steps 1 and 2). 1.1 Maximum severity of diarrhea 1.2 Maximum severity of nausea 1.3 Use of antimotility or antiemetic therapy 1.4 Development of adverse events (AEs) other than nausea and diarrhea 1.5 Development of laboratory abnormalities, e.g. lipids, transaminases 1.6 Development of treatment-limiting toxicity 1.7 Plasma HIV-1 RNA suppression to 50 copies/mL 1.8 Level of symptoms distress 2 To compare the pharmacokinetics of once daily liquid and capsules of LPV/r at week 2 of Steps 1 and 2 3 To determine the proportion of subjects who choose each of the therapeutic options at start of Step 3 4 The stated preference for liquid or capsules, and the degree of like or dislike of each in those who choose an option other than once daily LPV/r at start of Step 3 5 To determine the proportion of screened individuals who choose not to be randomized after the liquid LPV/r taste test at the time of enrollment into the study 6 The determine rates of plasma HIV-1 RNA 50 copies/mL at the end of Step 3