A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
Status:
Completed
Trial end date:
2001-09-01
Target enrollment:
Participant gender:
Summary
This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A
in HIV positive patients on a stable antiretroviral regimen. Dose response and safety
associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily)
of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative
subjects will be recruited as a control for cortisol secretion only and will not receive
study medication.