A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
Information source: Samaritan Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: SP01A (Drug)
Phase: Phase 1/Phase 2
Sponsored by: Samaritan Pharmaceuticals, Inc
Official(s) and/or principal investigator(s):
Stephen J Brown, MD, Principal Investigator, Affiliation: AIDS Research Alliance of West Hollywood
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
Official title: A Pharmacokinetic and Safety Study of Procaine HCl in HIV-1 Infected Patients
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Mean viral load reduction (log10) over 8 weeks
Maximal viral load suppression (LDL <50 & 400) over 8 weeks
Cortisol reduction over 8 weeks
Secondary outcome: Improvement in quality of life indices (Whalen Scale) over 8 weeks
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 antiretroviral therapy. Additionally, a group of six HIV-negative subjects (group
E) is being recruited as a control for cortisol secretion. This group will not receive study
medication nor will they be evaluated for dose response or safety parameters.
DISCUSSION OF STUDY DESIGN, INCLUDING CONTROL GROUP Patients will receive the following doses
of SP01A and will be divided into a low dose and high dose group for further analyses. There
will be two segments within the low dose group. Group A will receive 200 mg of SP01A once per
day. Group B will be administered 200 mg of SP01A twice daily. Similarly, there will be two
segments in the high dose group. Group C will be treated with 200 mg of SP01A three times
per day, while Group D will be administered 400 mg of SP01A twice daily.
A fifth group will also be introduced. This group, Group E, will serve as a control group
and not receive any treatment.
The study will be conducted at a single investigative center (AIDS ReSearch Alliance, West
Hollywood, CA). Six subjects with a diagnosis of HIV who are also receiving triple
combination antiretroviral therapy and have been so doing for a minimum of 2 months are
planned per group. Patients will be admitted to an in-patient facility for 72 hours. After
an initial night to acclimate the patients to the facility, a 24-hour measurement of cortisol
secretion in blood and urine will be conducted. After this is complete, patients will
receive an initial single dose of SP01A orally. (200 mg SP-01A for group A, 400 mg for group
B, 600 mg for group C, and 800 mg for group D). Blood and urine samples will also be
collected for 24 hours to further evaluate the safety of the study medication. Patients will
then be discharged from the facility.
After a 4-day washout, patients will return to the facility to start an 8-week dose-response
study, sequentially using the four doses that will now be divided (200 mg daily for group A,
200 mg twice a day for group B, 200 mg three times per day for group C, and 400 mg twice
daily for group D).
Subjects will return to the study center the day they are screened and as close to the same
day of the week as practical during Weeks 1 (baseline), 2, 3, 4, 5, 6, 7, 8 (end of
treatment) and 10 (post-treatment for examinations and specimen collection, as well as
evaluation of reactions to study treatment). At the end of the 8-week drug administration
period, patients will again be admitted to an in-patient facility for 72 hours. As before,
patients will have an initial night to acclimate to the facility, followed by a 24-hour
measurement of cortisol secretion in blood and urine. In the morning, following and ending
the 24 hour basal cortisol secretion, patients in the four successive groups (A, B, C, and
D), will receive their last dose of medication. They will also give their last blood and
urine samples over the next 24 hours for additional safety sample collection. The total
duration of study subject participation will be 11 weeks.
The six HIV negative subjects will be enrolled in group E. After an initial night to
acclimate to the facility, blood and urine samples will be collected to determine baseline 24
hour blood and urine cortisol secretion. Patients will then be discharged. No study
medication will be given to patients in group E.
Minimum age: 18 Years.
Maximum age: N/A.
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.
1. Known or suspected allergy to procaine hydrochloride.
2. Patients taking DHEA supplementation or oral ketoconazole (which have anticortisol
3. Patients using sulfonamides (including Septra/Bactrim).
4. Required use of sulfonamides, eg, Septra/Bactrim. (Procaine hydrochloride may
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
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
Locations and Contacts
AIDS Research Alliance of West Hollywood, West Hollywood, California 90069, United States
Starting date: September 1997
Ending date: September 2001
Last updated: March 31, 2006