Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)

NCT06580873 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: REB-24-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

HIV-1-infection; Opioid Use Disorder

Keywords

Antiretroviral Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in dosing of DTG/3TC

  Through study completion, an average of 1 year.

• Changes in dosing of OAT

  Through study completion, an average of 1 year.

• Evidence of recreational drug use while maintaining suppression

  Assessed at 48 weeks post-switch.

• Changes in serum creatinine and non-fasting lipids

  Assessed at 48 weeks post-switch.

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

  Assessed at 48 weeks post-switch.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: DOVATO

Interventions

DOVATO DRUG

HIV-1 medication

Also known as: Dolutegravir/Lamivudine

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• CD4 ≥ 200 cells/mL at screening
• Prescribed opioid agonist therapy (OAT) with oral methadone, sublingual buprenorphine, subcutaneous buprenorphine, slow-release oral morphine, or any combination thereof for at least 3 months prior to screening and deemed stable on OAT by the investigator
• Ability to remain adherent to medications and study protocol as per investigator opinion
• Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening

You may not qualify if:

• 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
• Concomitant use of drugs with contraindication or unmanageable drug interactions with any component of DTG/3TC
• Alanine transferase (ALT) greater than 5 times the upper limit of normal (ULN), or ALT greater than 3 times the ULN and bilirubin greater than 1.5 times the ULN (with \>35% direct bilirubin)
• Has an estimated glomerular filtration rate (eGFR; by MDRD equation) \< 30 mL/min/1.73m2
• Severe hepatic impairment (Class C or greater) by Child-Pugh classification
• Is pregnant, planning to get pregnant, or lactating
• Involved in any other interventional HIV study during the study period
• Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Saskatchewan Health Authority

Regina, Saskatchewan, S4P 0W5, Canada

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

dolutegravir; Lamivudine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Central Study Contacts

Jones Kalyniuk, MSc

CONTACT

306-766-4034; jones.kalyniuk@saskhealthauthority.ca

Sarah Craddock, HIM

CONTACT

306-766-0576; sarah.craddock@saskhealthauthority.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr. Alexander Wong

Model Details: This study is a single-arm, open-label, prospective interventional cohort study.

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)