Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299338
Status:
COMPLETED
Last Update Posted:
2006-04-03
First Post:
2006-03-02
Brief Title:
A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients
Sponsor:
Samaritan Pharmaceuticals Inc
Organization:
Samaritan Pharmaceuticals Inc
Study Overview
Official Title:
A Pharmacokinetic and Safety Study of Procaine HCl in HIV-1 Infected Patients
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This a Phase III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None