HIV InfectionsPhase 1/2NCT00299338
A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
A Phase 1/2 study testing SP01A in people with HIV Infections, run by Samaritan Pharmaceuticals, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- SP01A
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Sep 2001
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Research Alliance of West Hollywood
West Hollywood, California, 90069
About this study
Official title: A Pharmacokinetic and Safety Study of Procaine HCl in HIV-1 Infected Patients
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.
Read the 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 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.
- Conditions
- HIV Infections
- Being tested
- SP01A
- Keywords
- HIV, AIDS, CD4, HAART, antiretroviral, treatment failure, resistance, CCR4, CXCR5, gp120, gp41, cholesterol, lipid rafts, intracellular fluid, receptors, chemokine, antigens, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP01ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean viral load reduction (log10) over 8 weeks
Maximal viral load suppression (LDL <50 & 400) over 8 weeks
Cortisol reduction over 8 weeks
Secondary outcomes (1)
Improvement in quality of life indices (Whalen Scale) over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startSep 1997
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Samaritan Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen J Brown, MD, Principal investigator, AIDS Research Alliance of West Hollywood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299338
- Sponsor's protocol ID
- SP01A-SII-101
- Status last verified
- Mar 2006
- First submitted
- 2 Mar 2006
- Last updated
- 3 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Safety Study of Procaine HCl in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00299338
- Acronym / sponsor ID
- SP01A-SII-101
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, CD4, HAART, antiretroviral, treatment failure, resistance, CCR4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Samaritan Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 1997
- Study completion
- Sep 2001
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP01A | Drug | – |
Primary outcome
Mean viral load reduction (log10) over 8 weeks
Maximal viral load suppression (LDL <50 & 400) over 8 weeks
Cortisol reduction over 8 weeks
1 secondary outcome
Improvement in quality of life indices (Whalen Scale) over 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Brown, MD principal investigator
AIDS Research Alliance of West Hollywood
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SP01A in people with HIV Infections, run by Samaritan Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean viral load reduction (log10) over 8 weeks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2006.