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In antiretroviral-naive patients Plasma HIV RNA CD4 cell count Saquinavir 1800 mg/day plus AZT 600 mg/day 1.5-log peak decrease at 2 weeks Median 99-cell increase still present at 20 weeks Saquinavir monotherapy (control arm) 0.6-log median decrease at 2 weeks 65-cell increase at 2 weeks ACTG 229: 300 patients with advanced HIV disease, previously treated with AZT Plasma HIV RNA CD4 cell count Saquinavir plus AZT plus ddC Reduction significantly greater than in control arms (saquinavir plus AZT and AZT plus ddC) Increase significantly greater than in control arms (saquinavir plus AZT and AZT plus ddC) Differences from baseline persisted after 48 weeks; viral load and CD4 cell count tended to return to pretreatment levels over time Pilot high-dose trial Saquinavir monotherapy 7200 mg/day Nearly 2-log reduction in plasma HIV RNA

Saquinavir side effects: Mild in intensity and considered unrelated to saquinavir therapy.Saquinavir resistance: In various Phase I/II trials of saquinavir, drug-resistant strains of HIV have been isolated in 50% to 60% of patients after one year of treatment.