The Danish protease inhibitor study: A randomized study comparing the virological efficacy of 3 protease inhibitor-containing regimens for the treatment of human immunodeficiency virus type 1 infection

The Danish Protease Inhibitor (PI) Study has enrolled 318 human immunodefic iency virus (HIV)-infected, PI-naive patients for the purpose of comparing 3 PI-containing regimens for the treatment of HIV infection. The regimens i nclude 2 nucleoside analogues in combination with indinavir (Idr), ritonavi r (Rtv), or Rtv and saquinavir (Rtv/Sqv). Similar percentages of patients i n the 3 study arms achieved reduced levels (less than or equal to 20 copies /mL) of HIV RNA. In the area under the curve minus baseline analyses, a bet ter response was found in the Rtv/Sqv arm than in the Rtv arm. No differenc e was found when comparing Rtv/Sqv with Idr and Rtv with Idr. Patients in t he 3 arms had comparable increases in CD4 cell counts. At 72 weeks of follo w-up, there was no statistical difference between arms for the primary stud y end point (less than or equal to 20 HIV RNA copies/mL); however, some of the additional analyses indicated an advantage for the Rtv/Sqv arm, especia lly when compared with the Rtv arm.