NV15355C:SAQUINAVIR + 2 NUCLEOSIDE ANTIRETROVIRAL DRUGS IN HIV INFECT

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Analyses, in HIV infected patients, of the relationship between exposure to saquinavir and laboratory markers of HIV disease activity have shown that increased exposure result in increased suppression of viral replication and increased elevation of CD4 counts in the peripheral blood. The development of a new, soft-gelatin capsule formulation of saquinavir has provided the means to achieve exposures of saquinavir on the order of 8 times that seen with the standard dosing of the currently available hard gelatin capsule formulation without the limitation imposed by the large numbers of capsules needed to achieve high exposures. Available data from volunteers and patients who have taken doses to reach high exposures show that the high exposures are well tolerated. Modeling of the relationship between exposure of saquinavir and the change in viral load over time implies that dosing saquinavir at high doses would provide limited improvement in the antiviral response because the exposure-response curve has flattened. The purpose of this study is to see if adding saquinavir to other treatments for HIV infection are safe and if it adds to the ability of treatments to slow down the growth of HIV.