Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)
NCT Number: NCT06580873
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: HIV-1-infection|Opioid Use Disorder
Interventions: DRUG: DOVATO
Sponsor: Saskatchewan Health Authority - Regina Area
Collaborators: ViiV Healthcare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2027-10-31
Locations: Saskatchewan Health Authority, Regina, Saskatchewan, S4P 0W5, Canada

Summary:
The goal of this clinical trial is to determine the efficacy of Dolutegravir/Lamivudine (DTG/3TC), or "Dovato", in virally-suppressed (HIV-1 RNA \< 200 copies/mL) 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 DTG/3TC 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 DTG/3TC as documented per standard process at each study visit, and any discontinuations of DTG/3TC due to AEs and SAEs as determined by the study investigator;
3. the number of dosing changes in OAT attributable to DTG/3TC 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 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC;
5. any change from baseline values (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC of serum creatinine and non-fasting lipid parameters;
6. any change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC in HIV Treatment Satisfaction Questionnaire (Status) (HIVTSQs) scores;
7. the number of persons who remain virally suppressed (HIV RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC in conjunction with differing levels of adherence to DTG/3TC, and;
8. the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., 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

Primary Outcome Measures: Number of people living with HIV-1 on opioid agonist therapy (OAT) that remain virally suppressed 48 weeks post-switch to Dolutegravir/Lamivudine (DTG/3TC), The primary outcome assessed in the study is the number of individuals on OAT that remain virally suppressed (HIV RNA \< 200 copies/mL) 48 weeks after switching from their current suppressive antiretroviral therapy (ART) to DTG/3TC., Assessed at 48 weeks post-switch.
Secondary Outcome Measures: Changes in dosing of DTG/3TC, Number and type of adverse events (AEs) and serious adverse events (SAEs) attributable to DTG/3TC as documented per standard process at each study visit, and any discontinuations of DTG/3TC due to AEs and SAEs as determined by the study investigator., Through study completion, an average of 1 year.|Changes in dosing of OAT, Number of dosing changes in OAT attributable to DTG/3TC as determined by the study investigator and documented as per standard progress at each study visit., Through study completion, an average of 1 year.|Evidence of recreational drug use while maintaining suppression, The number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed (HIV-1 RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC., Assessed at 48 weeks post-switch.|Changes in serum creatinine and non-fasting lipids, Change from baseline values (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC of serum creatinine and non-fasting lipid parameters., Assessed at 48 weeks post-switch.|Change in HIV-1 Treatment Satisfaction Questionnaire (status) (HIVTSQs) scores, Change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC in HIVTSQs scores, ranging from 0 to 60, with 0 being the least satisfied with current HIV-1 treatment, and 60 being the most satisfied., Assessed at 48 weeks post-switch.|Measurement of total adherence to DTG/3TC based on viral suppression, The number of persons who remain virally suppressed (HIV-1 RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC in conjunction with differing levels of adherence to DTG/3TC., Assessed at 48 weeks post-switch.|Assessment of withdrawal symptoms or overdose, The number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., overdose events)., Through study completion, an average of 1 year.