SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients

Inclusion criteria

• ✓. Patient must be capable of giving informed consent prior to the screening visit.
• ✓. Patient is HIV-positive and has treatment-experienced virologic failure or documented resistance. Treatment-experienced virologic failure is defined as patients meeting the following criteria; (1) previous experience with antiretroviral therapy from at least two of the approved antiretroviral classes (i.e. treatment with a nucleoside reverse transcriptase inhibitor, and/or non-nucleoside reverse transcriptase inhibitor, and/or protease inhibitor) for three to six months; (2) increasing HIV RNA after treatment had previously lowered viral load to low or undetectable levels; (3) increased viremia (HIV RNA \> 5,000 copies/mL) in at least two viral load tests, one of which can be the screening viral load test, confirming their failing regimen. A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA \< 5,000 copies/mL) is not eligible for entry into the study.
• ✓. Patient has been off all antiviral medications including any unapproved or experimental treatment for at least 2 weeks prior to Study Day-1 (baseline).
• ✓. Patient has not taken any experimental medications for at least 4 weeks prior to Screening.
• ✓. Patient is at least 18 years of age and not older than 60 years of age.
• ✓. Patient is capable of adhering to the protocol.