Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299897
Status:
UNKNOWN
Last Update Posted:
2006-10-27
First Post:
2006-03-03
Brief Title:
SP01A The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients
Sponsor:
Samaritan Pharmaceuticals Inc
Organization:
Samaritan Pharmaceuticals Inc
Study Overview
Official Title:
A Multi-Center Double-Blind Randomized Placebo-Controlled Study of Orally Administered SP01A for 28 Days as Monotherapy Treatment in HIV-Infected Patients With Evidence of Resistance to Currently Available Antiretroviral Therapy
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 is a 28-day multi-center placebo-controlled study designed to look at the dose response efficacy and safety of SP01A given as a pill to be swallowed in the treatment of HIV-infected subjects
Samaritan has discovered that SP01A affects cholesterol binding which is directly implicated in the pathogenesis of HIV It has also been established that drugs of this nature exert an anti-HIV effect in-vitro These data suggest that SP01A has the potential to reduce HIV virus replication
One measurement of an HIV infected persons risk of progressing to AIDS is the number of viral particles of HIV in their blood called a viral load This study is designed to see if SP01A will lower the amount of HIV in an infected individuals blood Patients will be assigned by chance to 1 of 4 groups Neither the patient nor the study doctor or nurse will know which dose of the study drug the patient is taking or if heshe is receiving the placebo a capsule that looks like the study drug but does not contain any active ingredient
Study drug administration will continue for 28 days At the end of the 28-day study the patient will be offered testing of hisher virus for resistance to approved drugs genotype
Samaritan has discovered that SP01A affects cholesterol binding which is directly implicated in the pathogenesis of HIV It has also been established that drugs of this nature exert an anti-HIV effect in-vitro These data suggest that SP01A has the potential to reduce HIV virus replication
One measurement of an HIV infected persons risk of progressing to AIDS is the number of viral particles of HIV in their blood called a viral load This study is designed to see if SP01A will lower the amount of HIV in an infected individuals blood Patients will be assigned by chance to 1 of 4 groups Neither the patient nor the study doctor or nurse will know which dose of the study drug the patient is taking or if heshe is receiving the placebo a capsule that looks like the study drug but does not contain any active ingredient
Study drug administration will continue for 28 days At the end of the 28-day study the patient will be offered testing of hisher virus for resistance to approved drugs genotype
Detailed Description:
Currently approved antiretroviral medications target either the HIV viral reverse transcriptase RT Nucleoside Reverse Transcriptase Inhibitors NRTIs and Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs or the viral protease Protease Inhibitors PIs or inhibit viral fusion with target cells Fusion Inhibitors A regimen using a combination of these agents is considered the standard of care and when effective results in suppression of the virus below the detection limits
However the long-term use of antiretroviral therapy is sometimes hampered by poor compliance due to pill burden food restrictions and major side effects that impact Quality of Life Furthermore one of the major reasons for therapy failure is the emergence of resistant virus against one or more of the anti-HIV medications or to some extent an entire class of drug cross resistance
Enfuvirtide Fuzeon was recently approved as an HIV-1 fusionentry inhibitor a new class of treatment that prevents fusion of the HIV-1 virus to the CD4 cell membrane by preventing the conformational changes required for this fusion Since the mechanism of action of Enfuvirtide is different from other classes of anti-HIV medication it is effective in patients who have failed other therapies due to emergence of resistant virus However a recent study demonstrated the emergence of resistance to Enfuvirtide due to a mutation in viral gp41
The rapid rate of mutation of HIV-1 and conferred resistance of the virus to current therapies continues to necessitate a need for additional therapeutic agents To that end a hypothesis has been suggested regarding the immuno-modulating and anti-viral effects of SP01A in the treatment of HIV infection
SP01A may affect cholesterol binding which is directly implicated in the pathogenesis of HIV Several observations have also established that inhibitors of cholesterol synthesis inhibit cell fusion formation induced by HIV-l and that drugs extracting cholesterol from the cellular membrane exert an anti-HIV-1 effect in-vitro Taken together these data may suggest that procaine hydrochloride and SP01A reduces HIV-1 virus replication by modifying the cholesterol content of the cell membrane rendering it much more difficult for the virus to enter and infect the cell
There is an urgent need to develop improved new therapeutic agents SP01A which targets different viral or cellular components with a new mechanism of action is being developed and tested by Samaritan Pharmaceuticals Inc as a new anti-viral therapeutic agent
This multi-center double-blind randomized placebo-controlled study of orally administered SP01A as monotherapy in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy was designed to further evaluate the dose response efficacy and safety of SP01A HIV-positive patients will be evaluated during the pre-study period Following a 2-week washout period if required patients will be randomized into one of four study arms and all arms will initiate the 28-day monotherapy study The first arm will receive 200 mg of SP01A QID Arm Two will receive 200 mg bid The third arm will orally administer 400 mg bid Finally the fourth arm will receive placebo twice daily
During the treatment period patients will make five scheduled visits to the treatment facility on or about Days 1 8 15 22 and 29 During these visits patients will be monitored for viral load and general health parameters At the conclusion of the 28-day monotherapy study patients will have optimized viral testing for further treatment
On Day 43 patients will make their final visit to the treatment facility for post-study evaluation
However the long-term use of antiretroviral therapy is sometimes hampered by poor compliance due to pill burden food restrictions and major side effects that impact Quality of Life Furthermore one of the major reasons for therapy failure is the emergence of resistant virus against one or more of the anti-HIV medications or to some extent an entire class of drug cross resistance
Enfuvirtide Fuzeon was recently approved as an HIV-1 fusionentry inhibitor a new class of treatment that prevents fusion of the HIV-1 virus to the CD4 cell membrane by preventing the conformational changes required for this fusion Since the mechanism of action of Enfuvirtide is different from other classes of anti-HIV medication it is effective in patients who have failed other therapies due to emergence of resistant virus However a recent study demonstrated the emergence of resistance to Enfuvirtide due to a mutation in viral gp41
The rapid rate of mutation of HIV-1 and conferred resistance of the virus to current therapies continues to necessitate a need for additional therapeutic agents To that end a hypothesis has been suggested regarding the immuno-modulating and anti-viral effects of SP01A in the treatment of HIV infection
SP01A may affect cholesterol binding which is directly implicated in the pathogenesis of HIV Several observations have also established that inhibitors of cholesterol synthesis inhibit cell fusion formation induced by HIV-l and that drugs extracting cholesterol from the cellular membrane exert an anti-HIV-1 effect in-vitro Taken together these data may suggest that procaine hydrochloride and SP01A reduces HIV-1 virus replication by modifying the cholesterol content of the cell membrane rendering it much more difficult for the virus to enter and infect the cell
There is an urgent need to develop improved new therapeutic agents SP01A which targets different viral or cellular components with a new mechanism of action is being developed and tested by Samaritan Pharmaceuticals Inc as a new anti-viral therapeutic agent
This multi-center double-blind randomized placebo-controlled study of orally administered SP01A as monotherapy in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy was designed to further evaluate the dose response efficacy and safety of SP01A HIV-positive patients will be evaluated during the pre-study period Following a 2-week washout period if required patients will be randomized into one of four study arms and all arms will initiate the 28-day monotherapy study The first arm will receive 200 mg of SP01A QID Arm Two will receive 200 mg bid The third arm will orally administer 400 mg bid Finally the fourth arm will receive placebo twice daily
During the treatment period patients will make five scheduled visits to the treatment facility on or about Days 1 8 15 22 and 29 During these visits patients will be monitored for viral load and general health parameters At the conclusion of the 28-day monotherapy study patients will have optimized viral testing for further treatment
On Day 43 patients will make their final visit to the treatment facility for post-study evaluation
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