A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, AIDS, CD4, HAART, antiretroviral, treatment failure, resistance, CCR4, CXCR5, gp120, gp41, cholesterol, lipid rafts, intracellular fluid, receptors, chemokine, antigens, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- AIDS Research Alliance of West Hollywood