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Table 1 Clinical studies of raltegravir (RAL).

From: The use of integrase inhibitors in treatment-experienced patients

Study Phase No. of participants Study population Study Regimen Results
005 [25]      
Main II 178 HIV-infected, treatment-experienced; HIV RNA level > 5000 copies/mL; CD4cell count > 50 cells/μL OBT and RAL (200, 400, or 600 mg) or placebo twice daily At week 24, the proportions of patients with an HIV-1 RNA level < 50 copies/mL were 65% (RAL; 200 mg), 56% (RAL; 400 mg), 67%(RAL; 600 mg), and 13% (placebo)
Extension II 178 Same as above OBT and RAL (400 mg; beginning at week 24) or placebo twice daily At week 48, the proportions of patients with an HIV-1 RNA level < 50 copies/mL were 64% (RAL; 200 mg), 46% (RAL; 400 mg), 53%(RAL; 600 mg), and 9% (placebo)
BENCHMRK [14, 38]      
Trial 018 III 350 HIV-1-infected, treatment-experienced; HIV RNA level > 1000 copies/mL; CD4cell count OBT and RAL (400 mg) or placebo twice daily (randomized 2: 1) At week 48, the proportions of patients with an HIV RNA level < 50 copies/mL were 65%(RAL), and 31% (placebo)
Trial 019 III 349 Same as above Same as above At week 48, the proportions of patients with an HIV-1 RNA level < 50 copies/mL were 60%(RAL), and 35% (placebo)
SWITCHMRK [34]      
032 III 348 Well controlled (< 50 copies/ml for ≥ 3 mo.) on a stable lopinavir/r regimen in combination with at least 2 nucleosides Continue or switch from lopinavir/r to raltegravir At week 24 proportion of patients remaining < 50 copies/ml were 87% in lopinavir/r vs. 81% in raltegravir arm
033 III 354 same same At week 24 proportion of patients remaining < 50 copies/ml were 94% in lopinavir/r vs. 88% in raltegravir arm
TRIO(ANRS139) [30] IV 103 Failing patients with VL > 1000 copies/ml, naive and sensitive to study drugs Raltegravir + Darunavir/r + Etravirine At week 48, 89% below 50 copies/ml