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This study evaluated the safety and efficacy of switching HIV-infected patients with stable viral suppression on nonnucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) therapy to lopinavir/ritonavir (LPV/r) monotherapy.Eligible patients discontinued NNRTI and started LPV/r. Two weeks later NRTIs were stopped and LPV/r monotherapy was continued. Patients were seen every 4 weeks throughout the 48-week study.Twelve of 18 (66%) participants met the primary endpoint with HIV RNA75 copies/mL at week 48. Thirteen (72%) participants completed 48 weeks of LPV/r monotherapy, and 12 of 13 (92%) participants on treatment at week 48 had HIV RNA75 copies/mL. Ten (55%) of 18 patients maintained HIV RNA75 copies/mL at all time points. Two patients were withdrawn with virologic failure but demonstrated no evidence of virologic resistance. Three (17%) patients withdrew due to diarrhea, 2 with hyperglycemia at baseline developed diabetes mellitus, 7 (54%) required addition of or increase in lipid-lowering agents, but none had grade 3 or 4 hyperlipidemia.Results from this pilot study suggest that LPV/r monotherapy may be an option for management of HIV infection. Larger, randomized trials are warranted to evaluate the safety, efficacy, and patient population who might benefit from LPV/r monotherapy.

s of the 46th Annual ICAAC; September 27–30, 2006; San Francisco, CA. Poster A-0374. 8. Kumar PN CD, Steigbigel RT, et al. Efficacy of raltegravir, an integrase inhibitor, in combination with regimens containing enfuvitide, darunavir, or tipranavir in patients with tripleclass resistant virus: combined results from BENCHMRK-1 and BENCHMRK-2. In: Programs and abstracts of the 11th European AIDS Conference; October 24–27, 2007; Madrid, Spain, Poster P7.2/06. 1 10 100 1000 10000 100000 1000000 0 25 50 75 100 125 150 175 200 Follow-Up Period (weeks) H IV R N A ( co p ie s/ m L ) an d C D 4+ L ym p h o cy te (c el ls /μ L ) 0 20 40 60 80 100 120 140 160 180