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
Male and females, 18 years or older
HIV-1 infected
Prescribed a combination antiretroviral therapy (cART) regimen that may include any Department of Health and Human Services (DHHS) recommended or alternative regimens, which the treating physician considers is appropriate for their patient, except Dolutegravir/Lamivudine (DTG/3TC), or with DTG and 3TC as separate components of a single ART regimen at any point previously
HIV-1 RNA < 200 c/mL at screening and at least 3 months prior to screening
Co-infection with hepatitis B (HBsAg positive). Individuals who are negative for HBsAg and anti-HBs but positive for hepatitis B core antibody (anti-HBc) will be excluded if they have detectable HBV DNA (i.e. greater than 10 IU/mL).
History or presence of allergy to any component of DTG/3TC
Documented or suspected resistance to any component of DTG/3TC
Tuberculosis infection requiring treatment
Saskatchewan Health Authority - Regina Area
Lead sponsor
ViiV Healthcare
Collaborator