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

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00299338

Run by

Samaritan Pharmaceuticals, Inc

People needed

24

Starts

1997-09-01

Expected to finish

2001-09-01

Last updated by the study team

2006-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eighteen years of age or older (male or female).
• If female, agreed to use suitable contraception to prevent pregnancy.
• 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.
• Karnofsky Performance Status score of at least 60.
• No active opportunistic infection. Prophylaxis for MAl, CMV, Pneumocystis Pneumonia except Bactrim), or herpes was permitted.
• Current CD4 count >200.
• 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.
• Not taking any unapproved or experimental treatment for HIV, including antiretrovirals and immune modulators (such as interferons or interleukins).
• Capable and willing to provide informed consent.
• Agreed not to take Epoetin during the trial.
• 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.

You may not qualify if…

• Known or suspected allergy to procaine hydrochloride.
• Patients taking DHEA supplementation or oral ketoconazole (which have anticortisol properties).
• Patients using sulfonamides (including Septra/Bactrim).
• Required use of sulfonamides, eg, Septra/Bactrim. (Procaine hydrochloride may inactivate sulfonamides).
• 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.
• Patients with less than 6 months life expectancy.
• Patients with adrenal insufficiency (determined by screening ACTH stimulation test).
• Patients with lymphoma.
• Patients with active hepatitis (viral or drug induced).
• Patients with cancer, except peripheral Kaposi's sarcoma.
• Patients on dialysis.
• Patients who are pregnant.
• Female patients of childbearing age who can not use two forms of birth control or abstain from sexual intercourse during the trial.
• 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.

Where it is running

• AIDS Research Alliance of West Hollywood — West Hollywood, California, United States

Full record on ClinicalTrials.gov

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