For information regarding clinical recommendations, see PRECAUTIONS: DRUG INTERACTIONS, Table 6.

Description of Clinical Studies

In a randomized, double-blind clinical study (NV14256) in ZDV-experienced, HIV-infected patients, INVIRASE in combination with HIVID was shown to be superior to either INVIRASE or HIVID monotherapy in decreasing the cumulative incidence of clinical disease progression to AIDS-defining events or death. Furthermore, in a randomized study (ACTG229/NV14255), patients with advanced HIV infection with history of prolonged ZDV treatment and who were given INVIRASE 600 mg tid + ZDV + HIVID experienced greater increases in CD4 cell counts as compared to those who received INVIRASE + ZDV or HIVID + ZDV. It should be noted that HIV treatment regimens that were used in these initial clinical studies of INVIRASE are no longer considered standard of care.

Saquinavir gel capsule 1000 mg bid coadministered with ritonavir 100 mg bid was studied in a heterogeneous population of 148 HIV-infected patients (MaxCmin 1 study). At baseline 42 were treatment naïve and 106 were treatment experienced (of which 52 had an HIV RNA level < 400 copies/mL at baseline). Results showed that 91/148 (61%) subjects achieved and/or sustained an HIV RNA level < 400 copies/mL at the completion of 48 weeks.

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