Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444620
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-22
Brief Title:
BFTAF to DTG3TC Switch Study
Sponsor:
University of Nairobi
Organization:
University of Nairobi
Study Overview
Official Title:
Efficacy Safety and Tolerability of Switching to DTG3TC Single Tablet Regimen From BFTAF in Older Persons Living With HIV in Kenya
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
OBJECTIVE
To assess the efficacy and safety of switch to dolutegravir and lamivudine DTG3TC single tablet regimen from bictegravir emtricitabine and tenofovir alafenamide BFTAF in persons living with HIV aged 60 years old or more
METHODS
This is a phase 3b multi-center open-label single-arm clinical trial over 96 weeks The study will take place at two sites in Kenya Kenyatta National Hospital KNH and Jaramogi Oginga Odinga Teaching and Referral Hospital JOOTRH Study visits will take place at screening baseline and weeks 4 12 24 36 48 60 72 84 and 96 with a 6-week extension as required for confirming HIV-1 RNA levels A target of 240 participants from the ongoing BFTAF Elderly Switch Study will be enrolled Eligible participants will be switched from BFTAF to DTG3TC at enrollment and followed up for 96 weeks The primary endpoint will be the proportion of participants with plasma HIV-1 RNA 50 copiesmL Snapshot algorithm at Week 48 Analysis of the primary endpoint will be performed for the intention to treat - exposed ITT-E population using the FDA snapshot method
To assess the efficacy and safety of switch to dolutegravir and lamivudine DTG3TC single tablet regimen from bictegravir emtricitabine and tenofovir alafenamide BFTAF in persons living with HIV aged 60 years old or more
METHODS
This is a phase 3b multi-center open-label single-arm clinical trial over 96 weeks The study will take place at two sites in Kenya Kenyatta National Hospital KNH and Jaramogi Oginga Odinga Teaching and Referral Hospital JOOTRH Study visits will take place at screening baseline and weeks 4 12 24 36 48 60 72 84 and 96 with a 6-week extension as required for confirming HIV-1 RNA levels A target of 240 participants from the ongoing BFTAF Elderly Switch Study will be enrolled Eligible participants will be switched from BFTAF to DTG3TC at enrollment and followed up for 96 weeks The primary endpoint will be the proportion of participants with plasma HIV-1 RNA 50 copiesmL Snapshot algorithm at Week 48 Analysis of the primary endpoint will be performed for the intention to treat - exposed ITT-E population using the FDA snapshot method
Detailed Description:
BACKGROUND
Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression However they are associated with various adverse events including renal and bone disease anaemia mitochondrial toxicity and possible association with increased cardiovascular events Data from the ongoing BFTAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more hence the need for safe treatment options Two drug regimens 2DR have demonstrated non-inferiority to three drug regimens in patients who are treatment-naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity fewer adverse drug events and a lower drug burden
OVERALL STRATEGY
This is a phase 3b multi-centre open-label single-arm clinical trial over 96 weeks describing the efficacy of switching virally suppressed HIV-1 infected adults to DTG3TC dual therapy from their current BFTAF regimen The primary efficacy endpoint is the proportion of participants with viral load VL 50 copiesml at week 48
The study will take place at two sites in Kenya Kenyatta National Hospital KNH the largest teaching and referral hospital in Kenya and Jaramogi Oginga Odinga Teaching and Referral Hospital JOOTRH the largest teaching and referral hospital in the Nyanza region of Kenya The outpatient HIV clinics at these sites currently provide antiretroviral therapy ART to over 15000 persons living with HIV PWH combined These two sites are currently participating in the BFTAF-elderly study
Study visits will take place at screening baseline and weeks 4 12 24 36 48 and 96 with a 6-week extension as required for confirming HIV-1 RNA levels within the FDA snapshot window HIV-1 RNA viral load will be performed at screening and weeks 4 12 24 48 and 96 If HIV-1 RNA is 50 copiesml then a repeat test will be performed at least 2 weeks after the detectable result to confirm virological failure If the repeat HIV-1 RNA result is 50 copiesml this confirms protocol-defined virological failure PDVF and genotypic resistance testing will be performed for any repeat viral load 500 copiesml Other routine study investigations will include CD4 count complete blood count serum Cr renal biomarkers alanine transaminase ALT aspartate aminotransferase AST fasting lipids fasting glucose and patient satisfaction questionnaires HIVTSQ
METHODS
The anticipated sample size is 240 participants started on study treatment among patients on BFTAF therapy for at least 24 weeks and no prior virological failure defined as two consecutive HIV-1 RNA viral loads 50 copiesml separated by at least 2 weeks with a viral load of 50 copiesml for at least 12 weeks and aged 60 years or above
All participants will be recruited from the pool of patients who are exiting the BFTAF-elderly trial at the two study sites Those who provide written informed consent will be assessed for eligibility through review of their medical records history and physical examination
Patients who provide informed consent and meet all eligibility criteria after screening investigations will be enrolled in the study within 28 days of the screening investigations and will complete baseline investigations CD4 count fasting lipid profile and fasting glucose During the enrollment visit participants will be switched to DTG3TC two drug regimen
Participants will be engaged in the study for 96 weeks plus up to 28 days between screening and enrolment and a follow-up visit up to 28 days beyond the week 96 visit if required to confirm HIV-1 RNA within the FDA snapshot window
Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression However they are associated with various adverse events including renal and bone disease anaemia mitochondrial toxicity and possible association with increased cardiovascular events Data from the ongoing BFTAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more hence the need for safe treatment options Two drug regimens 2DR have demonstrated non-inferiority to three drug regimens in patients who are treatment-naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity fewer adverse drug events and a lower drug burden
OVERALL STRATEGY
This is a phase 3b multi-centre open-label single-arm clinical trial over 96 weeks describing the efficacy of switching virally suppressed HIV-1 infected adults to DTG3TC dual therapy from their current BFTAF regimen The primary efficacy endpoint is the proportion of participants with viral load VL 50 copiesml at week 48
The study will take place at two sites in Kenya Kenyatta National Hospital KNH the largest teaching and referral hospital in Kenya and Jaramogi Oginga Odinga Teaching and Referral Hospital JOOTRH the largest teaching and referral hospital in the Nyanza region of Kenya The outpatient HIV clinics at these sites currently provide antiretroviral therapy ART to over 15000 persons living with HIV PWH combined These two sites are currently participating in the BFTAF-elderly study
Study visits will take place at screening baseline and weeks 4 12 24 36 48 and 96 with a 6-week extension as required for confirming HIV-1 RNA levels within the FDA snapshot window HIV-1 RNA viral load will be performed at screening and weeks 4 12 24 48 and 96 If HIV-1 RNA is 50 copiesml then a repeat test will be performed at least 2 weeks after the detectable result to confirm virological failure If the repeat HIV-1 RNA result is 50 copiesml this confirms protocol-defined virological failure PDVF and genotypic resistance testing will be performed for any repeat viral load 500 copiesml Other routine study investigations will include CD4 count complete blood count serum Cr renal biomarkers alanine transaminase ALT aspartate aminotransferase AST fasting lipids fasting glucose and patient satisfaction questionnaires HIVTSQ
METHODS
The anticipated sample size is 240 participants started on study treatment among patients on BFTAF therapy for at least 24 weeks and no prior virological failure defined as two consecutive HIV-1 RNA viral loads 50 copiesml separated by at least 2 weeks with a viral load of 50 copiesml for at least 12 weeks and aged 60 years or above
All participants will be recruited from the pool of patients who are exiting the BFTAF-elderly trial at the two study sites Those who provide written informed consent will be assessed for eligibility through review of their medical records history and physical examination
Patients who provide informed consent and meet all eligibility criteria after screening investigations will be enrolled in the study within 28 days of the screening investigations and will complete baseline investigations CD4 count fasting lipid profile and fasting glucose During the enrollment visit participants will be switched to DTG3TC two drug regimen
Participants will be engaged in the study for 96 weeks plus up to 28 days between screening and enrolment and a follow-up visit up to 28 days beyond the week 96 visit if required to confirm HIV-1 RNA within the FDA snapshot window
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None