drugset / Trial / NCT00299338
A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 1997-09
- Primary completion
- —
- Completion
- 2001-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Procaine | Small molecule | 200 mg | Oral |
| Subject | Procaine | Small molecule | 400 mg | Oral |