A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients

• Status: Completed
• Trial end date: 2001-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samaritan Pharmaceuticals, Inc
• Treatments: Procaine

Criteria

Inclusion Criteria:

1. Eighteen years of age or older (male or female).

2. If female, agreed to use suitable contraception to prevent pregnancy.

3. HIV positive as confirmed by viral load using nucleic acid sequence based amplification (NASBA), or enzyme-linked immunosorbent assay (ELISA) and Western Blot, for cohort A, B, C, and D. HIV negative by ELISA and Western blot for cohort E.

4. Karnofsky Performance Status score of at least 60.

5. No active opportunistic infection. Prophylaxis for MAl, CMV, Pneumocystis Pneumonia except Bactrim), or herpes was permitted.

6. Current CD4 count >200.

7. Stable triple therapy antiretroviral regimen (cohorts A, B, C, and D) for the preceding 8 weeks and willing to make no changes in regimen during the study.

8. Not taking any unapproved or experimental treatment for HIV, including antiretrovirals and immune modulators (such as interferons or interleukins).

9. Capable and willing to provide informed consent.

10. Agreed not to take Epoetin during the trial.

11. Baseline laboratory values:

Neutrophils > 1000 cells/mm3; Platelets > 75,000 cells/mL; SGOT <3 times upper limit of normal; SGPT <3 times upper limit of normal; Creatinine <2.0 mg/dL.

Exclusion Criteria:

1. Known or suspected allergy to procaine hydrochloride.

2. Patients taking DHEA supplementation or oral ketoconazole (which have anticortisol properties).

3. Patients using sulfonamides (including Septra/Bactrim).

4. Required use of sulfonamides, eg, Septra/Bactrim. (Procaine hydrochloride may inactivate sulfonamides).

5. Patients with glaucoma using anti-cholinesterase inhibitors (Humorsol [demecarium bromide] echothiophate iodide, Floropryl [isoflurophate], Isopto-Eserine [physostigmine salicylate]). Anti-cholinesterase Inhibitors should not be used while on procaine hydrochloride, since procaine itself has some anti-cholinesterase activity.

6. Patients with less than 6 months life expectancy.

7. Patients with adrenal insufficiency (determined by screening ACTH stimulation test).

8. Patients with lymphoma.

9. Patients with active hepatitis (viral or drug induced).

10. Patients with cancer, except peripheral Kaposi's sarcoma.

11. Patients on dialysis.

12. Patients who are pregnant.

13. Female patients of childbearing age who can not use two forms of birth control or abstain from sexual intercourse during the trial.

14. Any medical, psychological, psychiatric, or substance use problem that, in the opinion of the Principal Investigator, interferes with the patient's ability to complete the study.