Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113412
Status:
UNKNOWN
Last Update Posted:
2006-03-22
First Post:
2005-06-07
Brief Title:
A Study of an Oral Entry Inhibitor SP01A in Treatment-Experienced HIV-Infected 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 As Monotherapy Treatment Of HIV-Infected Patients
Status:
UNKNOWN
Status Verified Date:
2006-03
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:
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 In a previous phase III study SP01A was observed to significantly lower the amount of HIV in blood improve quality of life how well subjects felt have a favorable safety profile minimal side effects and be well tolerated Moreover in in vitro testing SP01A 1 demonstrated comparable or greater efficacy than currently approved anti-HIV drugs in preventing HIV virus replication 2 was observed to have minimal toxic effect on human cells and 3 demonstrated significant efficacy in preventing virus replication of HIV virus strains that resist currently approved anti-HIV treatments Based on these results SP01A demonstrates promise as a new and novel anti-HIV treatment
The goal of this study is to further look at the dose response efficacy and safety of SP01A as monotherapy given as a capsule to be swallowed in the treatment of HIV-infected subjects The investigators want to see if SP01A will lower the amount of HIV in blood
Subjects will be assigned by chance to 1 of 4 groups Neither the subject nor the study doctor or nurse will know which dose of the study drug the subject is taking or if the subject is receiving the placebo a capsule that looks like the study drug but does not contain any active ingredient
At the end of the 10-day study the subject will be offered testing of their virus for resistance to approved drugs genotype and transferred to their physician for continued treatment with FDA-approved antiretroviral therapies If the subject experiences a side effect which continues past the end of the study they will be further monitored until the side effect goes away
The goal of this study is to further look at the dose response efficacy and safety of SP01A as monotherapy given as a capsule to be swallowed in the treatment of HIV-infected subjects The investigators want to see if SP01A will lower the amount of HIV in blood
Subjects will be assigned by chance to 1 of 4 groups Neither the subject nor the study doctor or nurse will know which dose of the study drug the subject is taking or if the subject is receiving the placebo a capsule that looks like the study drug but does not contain any active ingredient
At the end of the 10-day study the subject will be offered testing of their virus for resistance to approved drugs genotype and transferred to their physician for continued treatment with FDA-approved antiretroviral therapies If the subject experiences a side effect which continues past the end of the study they will be further monitored until the side effect goes away
Detailed Description:
This is a multi-center double-blind randomized placebo controlled Phase II study of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy This monotherapy study focuses on HIV-infected subjects who have previously failed antiretroviral regimens treatment failures defined as individuals with evidence of their viral load going up despite taking their anti-HIV drugs precisely as prescribed
HIV-positive subjects will be evaluated during the pre-study period Following a 4-week washout period to ensure that any previous anti-HIV drug no longer remains in their system all study groups will initiate the 10-day monotherapy study
At the conclusion of the 10-day monotherapy study subjects will have the option of having testing to determine the best anti-HIV treatment combination for their further treatment Further treatment if indicated will be limited to FDA-approved anti-HIV treatments
The primary objective of this study is to assess the dose-response efficacy and safety of orally administered SP01A as monotherapy treatment study drug alone of HIV-infected subjects with evidence of resistance to currently available anti-HIV drug therapy
The primary analysis is the reduction in viral load log10 within each SP01A study arm as well as within the placebo arm as measured from the first day of drug administration DAY-1 Baseline to the last day of study drug administration DAY-11 Study-End
The secondary analysis is the reduction in viral load log10 across SP01A active arms measured from DAY-1 Baseline to DAY-11 Study-End
The investigators may also test the HIV in each patients blood to determine if one or more HIV strains exists that are resistant to currently approved anti-HIV drugs This testing will be conducted at DAY-1 and Day-11 Additionally the investigators may test to determine whether the virus develops resistance to the study drug on DAY-11
Safety will be assessed at each visit by laboratory evaluations physical examination andor questioning for side effects In the event of side effects dosing of study drug may be stopped according to provisions outlined in the protocol
HIV-positive subjects will be evaluated during the pre-study period Following a 4-week washout period to ensure that any previous anti-HIV drug no longer remains in their system all study groups will initiate the 10-day monotherapy study
At the conclusion of the 10-day monotherapy study subjects will have the option of having testing to determine the best anti-HIV treatment combination for their further treatment Further treatment if indicated will be limited to FDA-approved anti-HIV treatments
The primary objective of this study is to assess the dose-response efficacy and safety of orally administered SP01A as monotherapy treatment study drug alone of HIV-infected subjects with evidence of resistance to currently available anti-HIV drug therapy
The primary analysis is the reduction in viral load log10 within each SP01A study arm as well as within the placebo arm as measured from the first day of drug administration DAY-1 Baseline to the last day of study drug administration DAY-11 Study-End
The secondary analysis is the reduction in viral load log10 across SP01A active arms measured from DAY-1 Baseline to DAY-11 Study-End
The investigators may also test the HIV in each patients blood to determine if one or more HIV strains exists that are resistant to currently approved anti-HIV drugs This testing will be conducted at DAY-1 and Day-11 Additionally the investigators may test to determine whether the virus develops resistance to the study drug on DAY-11
Safety will be assessed at each visit by laboratory evaluations physical examination andor questioning for side effects In the event of side effects dosing of study drug may be stopped according to provisions outlined in the protocol
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