Status:
COMPLETED
A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
Lead Sponsor:
Samaritan Pharmaceuticals, Inc
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 a...
Detailed Description
STUDY PLAN: DESCRIPTION This investigation will be a non-randomized, open-label study of four doses of SP01A in 24 individuals infected with HIV who are being treated with triple combination antiretro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 1997
Trial Type :
INTERVENTIONAL
End Date :
September 1 2001
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00299338
Start Date
September 1 1997
End Date
September 1 2001
Last Update
April 3 2006
Active Locations (1)
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1
AIDS Research Alliance of West Hollywood
West Hollywood, California, United States, 90069