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Session 61 Poster Session Antiretroviral Chemotherapy in Previously Treated Individuals Session Time: 4:30-6:30 pm Room 4E-F

422-W. Indinavir TID vs Indinavir/Ritonavir BID in Combination with AZT/3TC for HIV Infection in Nucleoside Pretreated Patients: HIV-NAT 005 76-Week Follow Up M. Boyd*1, 3, C. Duncombe1, 3, K. Ruxrungthram1, 2, M. Khongphattanayothin1, E. Hassink1, 4, P. Srasuebkul1, J. Sangkote1, P. Reiss4, M. Stek5, J. Lange1, 4, D. A. Cooper1, 3, P. Phanuphak1, and 2 1HIV-NAT, Thailand; 2Chulalongkorn Univ., Thailand; 3Univ. of New South Wales, Sydney, Australia; 4Univ. of Amsterdam, The Netherlands; 5Merck & Co., Whitehouse Station, NJ Background: Use of IDV may be simplified by addition of RTV. This permits BID dosing and removes need for dietary restrictions. There are limited randomised data on IDV/RTV BID compared to TID dosing. Methods: In this ongoing, prospective, randomised, open label study 106 patients were randomised to either IDV 800 mg (TID) or IDV 800 mg/RTV 100 mg (BID) in combination with AZT/3TC. All patients had at least 3 months AZT before entry. Efficacy was determined by HIV RNA and CD4 response (median and [IQR]). Safety and tolerability were assessed. Analysis is by intention to treat. Mann-Whitney, Student's t and chi2 tests tested differences between groups. Results: This study enrolled 104 patients (54 TID vs 50 BID; 67 males, 37 females). Arms were well balanced at baseline with a median log10HIV RNA of 4.0 (3.3-4.5) and CD4 of 168 (40-319) cells/mm3. At week 76 no significant differences were found in the decrease of log10 HIV RNA from baseline (1.6 [-2.72 to -0.36] TID, -1.8 [-2.43 to -0.18] BID), percentage of patients with VL < 50 copies/mL (69% TID, 66% BID), or median increase in CD4 cells from baseline (128 [11-204] TID, 101 [-4 - 156] BID). 20 patients permanently discontinued therapy (8 TID, 12 BID; p > 0.1). Drug interruptions/dose reductions occurred in 39 patients (30% TID, 48% BID; p=0.05). Grade 3/4 adverse events related to study medication occurred in 43 patients (38% TID, 48% BID; p >0.1). Hyperbilirubinaemia (>2.5xULN) occurred in 31 patients (24% TID, 36% BID; p > 0.1). Total cholesterol > 240 mg/dL was seen in 14 patients (5% TID and 22% BID; p > 0.1). Clinical nephrolithiasis was seen in 22 patients (17% TID, 26% BID; p > 0.1). Conclusions: After 76 weeks of therapy IDV/RTV twice a day remains as effective as the 3 times a day regimen. Both regimens are reasonably well tolerated, although there is a trend towards more adverse events, drug interruptions/dose reductions, study discontinuations and hyperlipidemia in the BID arm.

©2002 9th Conference on Retroviruses and Opportunistic Infections