Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580873
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Evaluation of Switch to DolutegravirLamivudine DTG3TC From Current Suppressive Antiretroviral Therapy in People Living With HIV PLWH Receiving Opioid Agonist Therapy OAT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Switch to DolutegravirLamivudine DTG3TC From Current Suppressive Antiretroviral Therapy in People Living With HIV PLWH Receiving Opioid Agonist Therapy OAT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
The goal of this clinical trial is to determine the efficacy of DolutegravirLamivudine DTG3TC or Dovato in virally-suppressed HIV-1 RNA 200 copiesmL individuals receiving opioid agonist therapy such as methadone buprenorphine slow-release morphine after switching from their current suppressive antiretroviral therapy ART
The main questions this trial seeks to answer are
1 whether people living with HIV-1 PLWH on opioid agonist therapy OAT remain virally suppressed after switching to DTG3TC from their current suppressive ART 48 weeks post-switch
2 the number and type of adverse events AEs and serious adverse events SAEs attributable to DTG3TC as documented per standard process at each study visit and any discontinuations of DTG3TC due to AEs and SAEs as determined by the study investigator
3 the number of dosing changes in OAT attributable to DTG3TC as determined by the study investigator and documented as per standard progress at each study visit
4 the number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed HIV-1 RNA 200 copiesmL at 48 weeks post-switch from current suppressive ART to DTG3TC
5 any change from baseline values ie day 0 to 48 weeks post-switch from current suppressive ART to DTG3TC of serum creatinine and non-fasting lipid parameters
6 any change from baseline value ie day 0 to 48 weeks post-switch from current suppressive ART to DTG3TC in HIV Treatment Satisfaction Questionnaire Status HIVTSQs scores
7 the number of persons who remain virally suppressed HIV RNA 200 copiesmL at 48 weeks post-switch from current suppressive ART to DTG3TC in conjunction with differing levels of adherence to DTG3TC and
8 the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report eg overdose events
During the course of the study participants will complete
A set of questionnaires
Blood draws
A review of adverse events and concomitant medications
ECG scans at screening and 48 weeks
Urine drug screening
Physical exams
Review of alcohol consumption
The main questions this trial seeks to answer are
1 whether people living with HIV-1 PLWH on opioid agonist therapy OAT remain virally suppressed after switching to DTG3TC from their current suppressive ART 48 weeks post-switch
2 the number and type of adverse events AEs and serious adverse events SAEs attributable to DTG3TC as documented per standard process at each study visit and any discontinuations of DTG3TC due to AEs and SAEs as determined by the study investigator
3 the number of dosing changes in OAT attributable to DTG3TC as determined by the study investigator and documented as per standard progress at each study visit
4 the number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed HIV-1 RNA 200 copiesmL at 48 weeks post-switch from current suppressive ART to DTG3TC
5 any change from baseline values ie day 0 to 48 weeks post-switch from current suppressive ART to DTG3TC of serum creatinine and non-fasting lipid parameters
6 any change from baseline value ie day 0 to 48 weeks post-switch from current suppressive ART to DTG3TC in HIV Treatment Satisfaction Questionnaire Status HIVTSQs scores
7 the number of persons who remain virally suppressed HIV RNA 200 copiesmL at 48 weeks post-switch from current suppressive ART to DTG3TC in conjunction with differing levels of adherence to DTG3TC and
8 the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report eg overdose events
During the course of the study participants will complete
A set of questionnaires
Blood draws
A review of adverse events and concomitant medications
ECG scans at screening and 48 weeks
Urine drug screening
Physical exams
Review of alcohol consumption
Detailed Description:
This study proposes to fill several important knowledge gaps regarding the safety and efficacy of switching to DolutegravirLamivudine DTG3TC in people living with HIV-1 PLWH on opioid agonist therapy OAT receiving care at the Infectious Diseases Clinic As of this time the Investigators are unaware of any real-world studies on the use of DTG3TC in PLWH who are on OAT PLWH using substances like fentanyl and crystal methamphetamine or those of Indigenous ethnicity
Additionally clinical data on the use of DTG3TC in young females is limited The Infectious Diseases Clinic is well positioned to help further the understanding of real-world use of DTG3TC among these understudied populations With the inherent unpredictable adherence to current ART in PLWH receiving OAT this study offers an opportunity to improve understanding of the real-world barrier to resistance of DTG3TC in this clinical setting The Principal Investigator proposes a single-arm open-label prospective interventional cohort study to evaluate the efficacy and safety of switch to DTG3TC from current suppressive ART in PLWH receiving OAT
Additionally clinical data on the use of DTG3TC in young females is limited The Infectious Diseases Clinic is well positioned to help further the understanding of real-world use of DTG3TC among these understudied populations With the inherent unpredictable adherence to current ART in PLWH receiving OAT this study offers an opportunity to improve understanding of the real-world barrier to resistance of DTG3TC in this clinical setting The Principal Investigator proposes a single-arm open-label prospective interventional cohort study to evaluate the efficacy and safety of switch to DTG3TC from current suppressive ART in PLWH receiving OAT
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