Table 1 Clinical studies of raltegravir (RAL).

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