( randomized controlled open-label Phas...)New Phase 3 Study Published in The Lancet Evaluates Efficacy and,Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination,Therapy in Treatment-Experienced Adults With HIV,Health

randomized, controlled, open-label Phase 3 trial in which 595 treatment-experienced patients were treated. Participants enrolled in the study were lopinavir/r-naive, HIV-1 infected adults with a viral load of >1000 HIV-1 RNA copies/mL and had previously failed highly active antiretroviral therapy (HAART) after at least 12 weeks, or were currently on treatment interruption. Patients with previous or current use of lopinavir/r, PREZISTA, Aptivus(R) (tipranavir)2, and/or Fuzeon(R) (enfuvirtide)3 were excluded, as were those currently receiving treatment with investigational antiretroviral drugs. Of the 595 patients, 31 percent were PI-naive and 82 percent were susceptible to four or more PIs.

Patients were randomized to receive PREZISTA/r (600 mg/100 mg) twice daily (n=298) or lopinavir/r (400 mg/100 mg) twice daily (n=297), plus OBR. Investigator-selected OBR for each participant was chosen based on resistance testing and prior treatment history and included a combination of nucleoside reverse transcriptase inhibitors (NRTIs) with or without non-nucleoside reverse transcriptase inhibitors (NNRTIs).

TITAN 48-week study results

In the per-protocol analysis of 554 patients, among patients randomized to the PREZISTA/r arm (n=286) vs. the lopinavir/r arm (n=293), the 48-week analysis showed for the primary endpoint that 77 percent of patients in the PREZISTA/r arm vs. 68 percent of patients in the lopinavir/r arm reached a viral load of <400 copies/mL (95 percent CI 2-16).

Pre-planned secondary endpoint findings (intent-to-treat analysis) include:

    -- 71 percent of patients in the PREZISTA/r arm reached an undetectable

       viral load (<50 copies/mL) vs. 60 percent of patients in the

       lopinavir/r arm, a statistically significant difference (p=0.005).

    -- 77 percent of patients in the PREZISTA/r arm achieved at least a 1

       log10 reduction in HIV RNA vs. 69 percent in the lopinavir/r arm, a

       statistically si
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