334   A 24-Week Randomized, Controlled, Open-Label Evaluation of Adherence and Convenience of Continuing Indinavir Versus Switching to Ritonavir/Indinavir 400 mg/400 mg BID (The NICE Study).

W. Harley*¹, E. DeJesus², M. Pistole³, M. Sension⁴, L. Garrett⁵, S. Nettler⁵, P. Jiang⁶, R. Rode⁶, T. Ashraf⁶, F. McMillan⁶, and A. J. Japour⁶for the Nice Study Investigators.
¹Charlotte, NC;²IDC Res. Initiative, Altamonte Springs, FL;³Washington, DC;⁴North Broward Hosp. District, Ft. Lauderdale, FL;⁵Ingenix PS, Chatham, NJ; and⁶Abbott Labs., Abbott Park, IL.

Background:Our objective was to evaluate the convenience and adherence in HIV-1-positive subjects randomized to receive ritonavir/indinavir (RTV/IDV) 400 mg/400 mg BID versus continuing indinavir-based antiretroviral therapy.

Methods:Subjects on an IDV-based regimen with HIV RNA <400 copies/mL were randomized to switch to RTV/IDV or maintain current therapy in this open-label study. Treatment was to be 24 weeks in duration. A validated medication-taking survey (MTS-6), consisting of questions concerning adherence and convenience, was to be administered at baseline and at weeks 4, 12, and 24.

Results:A total of 429 subjects were enrolled, with 322 on study at 12 weeks. Randomized subjects who switched to RTV/IDV reported that it was easier to take the PIs as prescribed, easier to take at the same time each day, and easier to coordinate with meals when compared with subjects remaining on IDV (p = 0.003, p = 0.036, and p < 0.001, respectively). At week 12, 87% of subjects on the RTV/IDV arm preferred this regimen to the previous regimen. Eighty-six percent of those subjects randomized to IDV preferred RTV/IDV when switching therapy at week 12. Physician preference was in accordance with subject preference. Twenty percent of subjects in the RTV/IDV arm and 11% in the IDV arm discontinued due to adverse events, with a median time to discontinuation of 39 days for the RTV/IDV arm and 106 days for the IDV arm. Viral rebound (>400 copies/mL) was seen in 6% of subjects in the RTV/IDV arm and 14% of subjects in the IDV arm.

Conclusions:The majority of subjects preferred the RTV/IDV regimen due to improved adherence and convenience. Both arms provided durable suppression in the majority of subjects.