DOVATO for HIV

Overseen By Jones Kalyniuk, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Saskatchewan Health Authority - Regina Area

Must be taking: Opioid agonist therapy

Must not be taking: Hepatitis B drugs

Disqualifiers: Hepatitis B, Tuberculosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 48 weeks

40 Participants Needed

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

Will I have to stop taking my current medications?

The trial requires participants to switch from their current HIV medications to Dovato (DTG/3TC). However, it does not specify if you need to stop other medications, so it's best to discuss this with the study team.

What data supports the effectiveness of the drug DOVATO (Dolutegravir/Lamivudine) for treating HIV?

Research shows that the combination of dolutegravir and lamivudine is effective and well-tolerated for treating HIV-1, with similar results to more complex regimens involving three or four drugs. Studies indicate it works well for both new patients and those switching from other treatments. ^{1 2 3 4 5}

Is DOVATO (Dolutegravir/Lamivudine) safe for humans?

Studies show that DOVATO, a combination of dolutegravir and lamivudine, is generally safe for people living with HIV, including those who are new to treatment and those switching from other medications. ^{1 3 6 7 8}

How is the drug DOVATO for HIV different from other treatments?

DOVATO is unique because it combines only two drugs, dolutegravir and lamivudine, into a single tablet, offering a simpler regimen compared to the standard 3- or 4-drug treatments for HIV. This two-drug regimen is effective and well-tolerated, making it a convenient option for people with HIV. ^{1 3 4 6 8}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants switch to Dolutegravir/Lamivudine (DTG/3TC) from their current suppressive ART and are monitored for viral suppression and adverse events

48 weeks

Regular visits (in-person) for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of viral suppression and adverse events

4 weeks

2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to further assess safety and efficacy

Long-term

Treatment Details

Interventions

• Dolutegravir/Lamivudine (DTG/3TC)

Trial Overview The 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

Group I: Treatment Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Saskatchewan Health Authority - Regina Area

Lead Sponsor

Trials

29

Recruited

5,400+

ViiV Healthcare

Industry Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Findings from Research

In a study involving 10,043 treatment-naive patients with HIV-1, the 2-drug regimen of dolutegravir and lamivudine (DTG+3TC) showed similar efficacy in achieving viral suppression at 48 weeks compared to traditional 3-drug regimens, with significant superiority over efavirenz-based treatments.

Safety outcomes, including adverse events and CD4 cell count changes, were broadly similar between DTG+3TC and the other regimens, indicating that DTG+3TC is a safe and effective alternative to more complex treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. Radford, M., Parks, DC., Ferrante, S., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Doing More With Less: Review of Dolutegravir-Lamivudine, a Novel Single-Tablet Regimen for Antiretroviral-Naïve Adults With HIV-1 Infection. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term data on the efficacy and tolerability of lamivudine plus dolutegravir as a switch strategy in a multi-centre cohort of HIV-1-infected, virologically suppressed patients. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Virological efficacy of switch to DTG plus 3TC in a retrospective observational cohort of suppressed HIV-1 patients with or without past M184V: the LAMRES study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparing Real-World Healthcare Costs Associated with Single-Tablet Regimens for HIV-1: The 2-Drug Regimen Dolutegravir/Lamivudine vs. Standard 3- or 4-Drug Regimens. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Life Experience on Dolutegravir and Lamivudine as Initial or Switch Therapy in a Silver Population Living with HIV. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Real-world implementation of dolutegravir plus lamivudine in people living with HIV in Southwest China. [2022]