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Antiretroviral

DOVATO for HIV

Phase 4

Waitlist Available

Research Sponsored by Saskatchewan Health Authority - Regina Area

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed a combination antiretroviral therapy (cART) regimen excluding Dolutegravir/Lamivudine (DTG/3TC) or with DTG and 3TC as separate components of a single ART regimen at any point previously

Be older than 18 years old

Must not have

Co-infection with hepatitis B (HBsAg positive)

Tuberculosis infection requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see if a new medication called Dolutegravir/Lamivudine (DTG/3TC) is effective in keeping HIV levels low in individuals who are also receiving

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include those attributable to DTG/3TC such as allergic reactions or liver problems indicated by yellow skin or eyesight issues; headaches; difficulty sleeping; tiredness; high temperature (fever); muscle pain; nausea. Serious adverse events may lead to discontinuation as determined by the investigator.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on HIV medication, but not specifically Dolutegravir/Lamivudine together.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am positive for hepatitis B.

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I am currently being treated for tuberculosis.

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My kidney function is severely reduced.

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I may be resistant to parts of my HIV medication.

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I am not taking any medications that would badly interact with DTG/3TC.

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My liver function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

Assessment of withdrawal symptoms or overdose

Change in HIV-1 Treatment Satisfaction Questionnaire (status) (HIVTSQs) scores

Changes in dosing of DTG/3TC

+4 more

Side effects data

From 2021 Phase 1 trial • 33 Patients • NCT04827134

Dry skin

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: DOVATO (DTG/3TC) Fasted

Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted

Cohort 2: DOVATO (DTG/3TC) Fed

Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DOVATO

2021

Completed Phase 1

~40

0 / 7Eligibility criteria met