Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214435
Status:
UNKNOWN
Last Update Posted:
2005-10-25
First Post:
2005-09-16
Brief Title:
Once Daily 3TC Efavirenz and ddI for HIV Infection
Sponsor:
407 Doctors
Organization:
407 Doctors
Study Overview
Official Title:
A Randomised Multi-Centre Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine Efavirenz and Didanosine Versus Continuation of Current Anti-Retroviral Regimen Delivered at Least Twice Daily
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Poor compliance is thought to be a major cause of treatment failure The TEddI study is a randomised multi-centre open-label study in well-controlled treatment-experienced HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral therapy versus continuation of current anti-retroviral regimen delivered at least twice daily
Detailed Description:
Rationale TEddI will enable a once-daily treatment strategy to be studied and provide information on effectiveness patient adherence and quality of life and the tolerability of such regimens
Hypothesis The study hypothesis is that an antiretroviral regimen comprising of three agents taken once daily will have higher levels of adherence than a regimen requiring more frequent dosing
Primary objective To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomised to receive either a once daily minimum 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing
Secondary objectives The secondary objectives of the study will include
To estimate the proportion of patients with treatment failure where treatment failure is defined as
HIV-1 RNA viral load of 400 copiesml on two consecutive occasions more than one month apart OR
Discontinuation of treatment for any reason where subsequent therapy does not comply with the study regimen change guidelines outlined in section 333
Proportion of patients with plasma HIV-RNA less than 50 copiesml using an ultrasensitive assay at 24 and 48 weeks
Change from baseline in CD4 cell count at 24 and 48 weeks
Changes from baseline in subjects quality of life at 24 and 48 weeks
Changes from baseline based on DASS 21 scores at 24 and 48 weeks
Incidence and severity of adverse events and abnormal laboratory values grade 3 4 at 24 and 48 weeks
Proportion of patients remaining on assigned treatment Study Design This is a randomised open-label multi-centre prospective 48-week study comparing a 3 or more drug once-daily antiretroviral regimen with any 3 or more drug regimen in which at least 1 drug must be taken at least twice daily
One hundred and twenty 120 subjects will be recruited and randomised in a 11 ratio to one of two open-label treatment regimens and will continue to receive randomised treatment until week 24
Arm 1 Once daily arm commence treatment with a once-a-day combination of licensed antiviral medications such as EFVddI3TC EFV3TCTDF or ATV3TCTDF
Arm 2 Continuation arm continue current ART minimum 3-drugs dosed twice daily or more frequently
Following week 24 patients will have the option to continue randomised treatment for a further 24 weeks or switch to the once daily treatment arm In all cases patients will be followed up for 48 weeks from the baseline visit
Hypothesis The study hypothesis is that an antiretroviral regimen comprising of three agents taken once daily will have higher levels of adherence than a regimen requiring more frequent dosing
Primary objective To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomised to receive either a once daily minimum 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing
Secondary objectives The secondary objectives of the study will include
To estimate the proportion of patients with treatment failure where treatment failure is defined as
HIV-1 RNA viral load of 400 copiesml on two consecutive occasions more than one month apart OR
Discontinuation of treatment for any reason where subsequent therapy does not comply with the study regimen change guidelines outlined in section 333
Proportion of patients with plasma HIV-RNA less than 50 copiesml using an ultrasensitive assay at 24 and 48 weeks
Change from baseline in CD4 cell count at 24 and 48 weeks
Changes from baseline in subjects quality of life at 24 and 48 weeks
Changes from baseline based on DASS 21 scores at 24 and 48 weeks
Incidence and severity of adverse events and abnormal laboratory values grade 3 4 at 24 and 48 weeks
Proportion of patients remaining on assigned treatment Study Design This is a randomised open-label multi-centre prospective 48-week study comparing a 3 or more drug once-daily antiretroviral regimen with any 3 or more drug regimen in which at least 1 drug must be taken at least twice daily
One hundred and twenty 120 subjects will be recruited and randomised in a 11 ratio to one of two open-label treatment regimens and will continue to receive randomised treatment until week 24
Arm 1 Once daily arm commence treatment with a once-a-day combination of licensed antiviral medications such as EFVddI3TC EFV3TCTDF or ATV3TCTDF
Arm 2 Continuation arm continue current ART minimum 3-drugs dosed twice daily or more frequently
Following week 24 patients will have the option to continue randomised treatment for a further 24 weeks or switch to the once daily treatment arm In all cases patients will be followed up for 48 weeks from the baseline visit
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