A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients

This is a multi-center, double-blind, randomized, placebo controlled Phase II study of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy. This monotherapy study focuses on HIV-infected subjects who have previously failed antiretroviral regimens (treatment failures; defined as individuals with evidence of their viral load going up despite taking their anti-HIV drugs precisely as prescribed). HIV-positive subjects will be evaluated during the pre-study period. Following a 4-week washout period (to ensure that any previous anti-HIV drug no longer remains in their system), all study groups will initiate the 10-day monotherapy study. At the conclusion of the 10-day monotherapy study, subjects will have the option of having testing to determine the best anti-HIV treatment combination for their further treatment. Further treatment, if indicated, will be limited to FDA-approved anti-HIV treatments. The primary objective of this study is to assess the dose-response, efficacy and safety of orally administered SP01A as monotherapy treatment (study drug alone) of HIV-infected subjects with evidence of resistance to currently available anti-HIV drug therapy. The primary analysis is the reduction in viral load (log10) within each SP01A study arm as well as within the placebo arm as measured from the first day of drug administration (DAY-1 (Baseline)) to the last day of study drug administration (DAY-11 (Study-End)). The secondary analysis is the reduction in viral load (log10) across SP01A active arms measured from DAY-1 (Baseline) to DAY-11 (Study-End). The investigators may also test the HIV in each patient's blood to determine if one or more HIV strains exists that are resistant to currently approved anti-HIV drugs. This testing will be conducted at DAY-1 and Day-11. Additionally, the investigators may test to determine whether the virus develops resistance to the study drug on DAY-11. Safety will be assessed at each visit by laboratory evaluations, physical examination and/or questioning for side effects. In the event of side effects, dosing of study drug may be stopped according to provisions outlined in the protocol.