Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
Study NCT ID:
NCT02659761
Status:
TERMINATED
Last Update Posted:
2024-05-09
First Post:
2016-01-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Triumeq As an Integrase Single Tablet Regimen in People With HIV Who Inject Drugs
Sponsor:
University College Dublin
Organization:
Study Overview
Official Title:
A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Use Switching From Existing ART or Starting Treatment After Discontinuation of ART
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision due to slow recruitment rates and no future recruitment foreseen
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAISTR
Brief Summary:
The purpose of this study is to assess the tolerability, adherence and efficacy of single tablet dolutegravir/abacavir/lamivudine antiretroviral therapy in people living with HIV with a history of injection drug use (IDU) switching from existing antiretroviral therapy (ART) or starting treatment after discontinuation of ART.
Detailed Description:
Dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI) that supports once-daily dosing without the need for pharmacokinetic boosting and may be co-formulated with other antiretrovirals into a single-tablet regimen (STR). With people living with HIV with injection drug use (IDU) being more prone to unplanned antiretroviral therapy (ART) discontinuation and suboptimal adherence, DTG offers a high genetic barrier to resistance, a profile that reduces drug-drug interactions, with better tolerability and its availability as single tablet regimen (STR) combined with abacavir and lamivudine (ABC/3TC) is likely to improve adherence.
The aims of this study include:
* To assess tolerability through self-reported adverse effects and directed symptom questionnaire
* To determine change in number and severity of reported ART-related adverse effects from baseline to week 48 and 96
* To determine change in health-related quality of life (HRQOL) from baseline to week 48 and 96
* To determine change in frailty score from baseline to week 48 and 96
* To determine the percentage of subject with unscheduled ART discontinuations/ interruptions over 96 weeks
* To determine the estimated number of weeks of missed ART over 48 and 96 weeks of follow-up
* To determine change from baseline of medication possession ratio (MPR) at 48 and 96 weeks or adherence score as measured by an antiretroviral therapy medication self-report form at the same time points
* To determine the percentage of subjects with HIV RNA\<40 copies/mL at 96 weeks
* To determine change in genotypic resistance profiles in subjects experiencing virological failure
* To determine change in CD4+ T-cell counts through 96 weeks
* To determine change in bone mineral density through 96 weeks
* To determine the number of subjects with any adverse and any serious adverse events (SAE) from baseline to week 96
* To determine the number of subject with Grade 1 to 4 laboratory abnormalities from baseline to week 96
This is a prospective, single arm, open-label 96 weeks clinical trial. Study subjects will be followed for 96 weeks post enrolment, with regular clinical evaluations, laboratory evaluations, safety and adherence assessment, quality of life and bone mineral density (BMD) measured at regular intervals.
The aims of this study include:
* To assess tolerability through self-reported adverse effects and directed symptom questionnaire
* To determine change in number and severity of reported ART-related adverse effects from baseline to week 48 and 96
* To determine change in health-related quality of life (HRQOL) from baseline to week 48 and 96
* To determine change in frailty score from baseline to week 48 and 96
* To determine the percentage of subject with unscheduled ART discontinuations/ interruptions over 96 weeks
* To determine the estimated number of weeks of missed ART over 48 and 96 weeks of follow-up
* To determine change from baseline of medication possession ratio (MPR) at 48 and 96 weeks or adherence score as measured by an antiretroviral therapy medication self-report form at the same time points
* To determine the percentage of subjects with HIV RNA\<40 copies/mL at 96 weeks
* To determine change in genotypic resistance profiles in subjects experiencing virological failure
* To determine change in CD4+ T-cell counts through 96 weeks
* To determine change in bone mineral density through 96 weeks
* To determine the number of subjects with any adverse and any serious adverse events (SAE) from baseline to week 96
* To determine the number of subject with Grade 1 to 4 laboratory abnormalities from baseline to week 96
This is a prospective, single arm, open-label 96 weeks clinical trial. Study subjects will be followed for 96 weeks post enrolment, with regular clinical evaluations, laboratory evaluations, safety and adherence assessment, quality of life and bone mineral density (BMD) measured at regular intervals.
Study Oversight
Has Oversight DMC:
True
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?: