DOVATO for HIV

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Saskatchewan Health Authority - Regina Area

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

This trial is for HIV-positive individuals who are currently on a stable antiretroviral therapy and also receiving opioid agonist therapy. They must have maintained viral suppression (HIV-1 RNA < 200 copies/mL). Participants should not be planning to change their opioid treatment and must consent to regular blood draws, questionnaires, ECGs, urine screenings, and reviews of medication.

Inclusion Criteria

Ability to remain adherent to medications and study protocol as per investigator opinion

I am 18 years old or older.

HIV-1 infected

See 5 more

Exclusion Criteria

History or presence of allergy to any component of DTG/3TC

I am positive for hepatitis B.

I am currently being treated for tuberculosis.

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Treatment Details

Interventions

Dolutegravir/Lamivudine (DTG/3TC) (Antiretroviral)

Trial OverviewThe study tests if switching HIV patients on opioid agonist therapy from their current ART to Dolutegravir/Lamivudine (DTG/3TC or 'Dovato') keeps the virus suppressed after 48 weeks. It will monitor adverse events related to DTG/3TC, changes in OAT dosing due to DTG/3TC, substance use impact on viral suppression, kidney function changes, lipid levels shifts, patient satisfaction with treatment and symptoms of opioid withdrawal or overdose.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Switch to Dolutegravir/Lamivudine ("DOVATO") from current suppressive antiretroviral therapy in people living with HIV-1 receiving opioid agonist therapy.