HIV-1-infectionPhase 4NCT06580873
Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)
A Phase 4 study testing DOVATO in people with HIV-1-infection and Opioid Use Disorder, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Opioid Use Disorder
- What is being tested?
- DOVATO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2024to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Saskatchewan Health Authority
Regina, Saskatchewan, S4P 0W5
Jones Kalyniuk, MSc., 306-766-4034, jones.kalyniuk@saskhealthauthority.ca
Sarah Craddock, HIM, 306-766-0576, sarah.craddock@saskhealthauthority.ca
About this study
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:
Read more
- 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;
- 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;
- 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;
- 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;
- 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;
- 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;
- 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;
- 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
Read the detailed description
This study proposes to fill several important knowledge gaps regarding the safety and efficacy of switching to Dolutegravir/Lamivudine (DTG/3TC) in people living with HIV-1 (PLWH) on opioid agonist therapy (OAT) receiving care at the Infectious Diseases Clinic. As of this time, the Investigators are unaware of any real-world studies on the use of DTG/3TC in PLWH who are on OAT, PLWH using substances like fentanyl and crystal methamphetamine, or those of Indigenous ethnicity.
Additionally, clinical data on the use of DTG/3TC in young females is limited. The Infectious Diseases Clinic is well positioned to help further the understanding of real-world use of DTG/3TC among these understudied populations. With the inherent unpredictable adherence to current ART in PLWH receiving OAT, this study offers an opportunity to improve understanding of the real-world barrier to resistance of DTG/3TC in this clinical setting. The Principal Investigator proposes a single-arm, open-label, prospective interventional cohort study to evaluate the efficacy, and safety of switch to DTG/3TC from current suppressive ART in PLWH receiving OAT.
- Conditions
- HIV-1-infection, Opioid Use Disorder
- Being tested
- DOVATO
- Keywords
- Antiretroviral Therapy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOVATODrug
Also called Dolutegravir/Lamivudine
HIV-1 medication
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Switch to Dolutegravir/Lamivudine ("DOVATO") from current suppressive antiretroviral therapy in people living with HIV-1 receiving opioid agonist therapy. Receives: Drug: DOVATO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 48 weeks post-switch.
Secondary outcomes (7)
Changes in dosing of DTG/3TC
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.
Measured: Through study completion, an average of 1 year.
Changes in dosing of OAT
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.
Measured: Through study completion, an average of 1 year.
Evidence of recreational drug use while maintaining suppression
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.
Measured: Assessed at 48 weeks post-switch.
Changes in serum creatinine and non-fasting lipids
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.
Measured: Assessed at 48 weeks post-switch.
Change in HIV-1 Treatment Satisfaction Questionnaire (status) (HIVTSQs) scores
Change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC in HIVTSQs scores, ranging from 0 to 60, with 0 being the least satisfied with current HIV-1 treatment, and 60 being the most satisfied.
Measured: Assessed at 48 weeks post-switch.
Measurement of total adherence to DTG/3TC based on viral suppression
The number of persons who remain virally suppressed (HIV-1 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.
Measured: Assessed at 48 weeks post-switch.
Assessment of withdrawal symptoms or overdose
The number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., overdose events).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start30 Sep 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm, open-label, prospective interventional cohort study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Alexander Wong, MD, Saskatchewan Health Authority - Regina Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580873
- Sponsor's protocol ID
- REB-24-04
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)
- ClinicalTrials.gov ID
- NCT06580873
- Acronym / sponsor ID
- REB-24-04
- Conditions
- HIV-1-infection, Opioid Use Disorder
- Keywords
- Antiretroviral Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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;
- 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;
- 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;
- 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;
- 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;
- 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
Detailed description
This study proposes to fill several important knowledge gaps regarding the safety and efficacy of switching to Dolutegravir/Lamivudine (DTG/3TC) in people living with HIV-1 (PLWH) on opioid agonist therapy (OAT) receiving care at the Infectious Diseases Clinic. As of this time, the Investigators are unaware of any real-world studies on the use of DTG/3TC in PLWH who are on OAT, PLWH using substances like fentanyl and crystal methamphetamine, or those of Indigenous ethnicity.
Additionally, clinical data on the use of DTG/3TC in young females is limited. The Infectious Diseases Clinic is well positioned to help further the understanding of real-world use of DTG/3TC among these understudied populations. With the inherent unpredictable adherence to current ART in PLWH receiving OAT, this study offers an opportunity to improve understanding of the real-world barrier to resistance of DTG/3TC in this clinical setting. The Principal Investigator proposes a single-arm, open-label, prospective interventional cohort study to evaluate the efficacy, and safety of switch to DTG/3TC from current suppressive ART in PLWH receiving OAT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm, open-label, prospective interventional cohort study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: DOVATOSwitch to Dolutegravir/Lamivudine ("DOVATO") from current suppressive antiretroviral therapy in people living with HIV-1 receiving opioid agonist therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOVATOAlso: Dolutegravir/LamivudineHIV-1 medication | Drug | Treatment Arm |
Primary outcome
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)
Time frame: Assessed at 48 weeks post-switch.
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.
7 secondary outcomes
Changes in dosing of DTG/3TC
Time frame: Through study completion, an average of 1 year.
Changes in dosing of OAT
Time frame: Through study completion, an average of 1 year.
Evidence of recreational drug use while maintaining suppression
Time frame: Assessed at 48 weeks post-switch.
Changes in serum creatinine and non-fasting lipids
Time frame: Assessed at 48 weeks post-switch.
Change in HIV-1 Treatment Satisfaction Questionnaire (status) (HIVTSQs) scores
Time frame: Assessed at 48 weeks post-switch.
Measurement of total adherence to DTG/3TC based on viral suppression
Time frame: Assessed at 48 weeks post-switch.
Assessment of withdrawal symptoms or overdose
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DOVATO in people with HIV-1-infection and Opioid Use Disorder, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jones Kalyniuk, MSc (306-766-4034, jones.kalyniuk@saskhealthauthority.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Assessed at 48 weeks post-switch.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.