A phase II trial of dual protease inhibitor therapy: Amprenavir in combination with indinavir, nelfinavir, or saquinavir

This study evaluated dual protease inhibitor (PI) regimens containing ampre navir (APV) in PI-naive, HIV-1-infected patients over 48 weeks. Patients we re randomized to 800-mg APV combined with 800-mg indinavir (IDV), 750-mg ne lfinavir (NFV), or 800-mg saquinavir-soft gel capsule (SGV-SGC), all three times daily without nucleoside reverse transcriptase inhibitors, or APV giv en alone for 3 weeks and then with 150-mg lamivudine (3TC) and 300-mg zidov udine (ZDV), twice daily. Dual PI therapy demonstrated substantial antivira l activity and was generally safe and well tolerated. Eight patients had vi rologic failure: 5 were receiving dual PI therapy and 3 were in the APV/3TC /ZDV arm. The protease 150V mutation characteristic of APV resistance was n ot observed, although other key PI mutations were selected in 4 patients fa iling therapy, 2 of whom had PI resistance at baseline.