PURPOSE: To compare activity and safety of a regimen containing lopinavir/ritonavir (LPV/r) + fosamprenavir (FPV) to regimens with LPV/r or FPV + r and to test the hypothesis that a ritonavir-enhanced dual protease inhibitor (PI) regimen has better antiviral activity. METHOD: This study was a multicenter, open-label, randomized study. HIV-infected adults with prior PI failure were selectively randomized based on prior PI experience to either LPV/r, FPV + r, or LPV/r + FPV. All patients received tenofovir DF and 1 to 2 nucleoside reverse transcriptase inhibitors. RESULTS: Baseline characteristics were similar across arms. Study enrollment and follow-up were stopped early (N = 56) because pharmacokinetic analyses showed significantly lower LPV and FPV exposures in the dual-PI arm. At Week 24, proportions achieving >1 log10 decline in HIV RNA or <50 copies/mL in the dual-PI versus single-PI arms combined were 75% vs. 61% in intent-to-treat (ITT, p = .17) and 100% vs. 64% in as-treated (AT) analyses (p = .02), respectively. Median CD4+ T cell/mm3 increases were 81 vs. 41 (ITT, p = .4) and 114 vs. 43 (AT, p = .08), respectively. Clinical events and toxicity rates were not different between arms. CONCLUSION: The trial was unable to show a difference between dual versus single PIs in ITT analyses but favored dual PIs in AT analyses.
RCT Entities:
PURPOSE: To compare activity and safety of a regimen containing lopinavir/ritonavir (LPV/r) + fosamprenavir (FPV) to regimens with LPV/r or FPV + r and to test the hypothesis that a ritonavir-enhanced dual protease inhibitor (PI) regimen has better antiviral activity. METHOD: This study was a multicenter, open-label, randomized study. HIV-infected adults with prior PI failure were selectively randomized based on prior PI experience to either LPV/r, FPV + r, or LPV/r + FPV. All patients received tenofovir DF and 1 to 2 nucleoside reverse transcriptase inhibitors. RESULTS: Baseline characteristics were similar across arms. Study enrollment and follow-up were stopped early (N = 56) because pharmacokinetic analyses showed significantly lower LPV and FPV exposures in the dual-PI arm. At Week 24, proportions achieving >1 log10 decline in HIV RNA or <50 copies/mL in the dual-PI versus single-PI arms combined were 75% vs. 61% in intent-to-treat (ITT, p = .17) and 100% vs. 64% in as-treated (AT) analyses (p = .02), respectively. Median CD4+ T cell/mm3 increases were 81 vs. 41 (ITT, p = .4) and 114 vs. 43 (AT, p = .08), respectively. Clinical events and toxicity rates were not different between arms. CONCLUSION: The trial was unable to show a difference between dual versus single PIs in ITT analyses but favored dual PIs in AT analyses.
Authors: Regina B Osih; Patrick Taffé; Martin Rickenbach; Angèle Gayet-Ageron; Luigia Elzi; Christoph Fux; Milos Opravil; Enos Bernasconi; Patrick Schmid; Huldrych F Günthard; Matthias Cavassini Journal: AIDS Res Hum Retroviruses Date: 2010-10-07 Impact factor: 2.205
Authors: Parya Saberi; Torsten B Neilands; Eric Vittinghoff; Mallory O Johnson; Margaret Chesney; Susan E Cohn Journal: AIDS Patient Care STDS Date: 2015-01-23 Impact factor: 5.078
Authors: Huichao Chen; David B Clifford; Lijuan Deng; Kunling Wu; Anthony J Lee; Ronald J Bosch; Sharon A Riddler; Ronald J Ellis; Scott R Evans Journal: J Neurovirol Date: 2013-12-03 Impact factor: 2.643
Authors: Julie B Dumond; Joseph Rigdon; Katie Mollan; Camlin Tierney; Angela D M Kashuba; Francesca Aweeka; Ann C Collier Journal: J Acquir Immune Defic Syndr Date: 2015-12-15 Impact factor: 3.731