Status:
NOT_YET_RECRUITING
Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)
Lead Sponsor:
Saskatchewan Health Authority - Regina Area
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-1-infection
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06580873
Start Date
September 30 2024
End Date
October 31 2027
Last Update
August 30 2024
Active Locations (1)
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1
Saskatchewan Health Authority
Regina, Saskatchewan, Canada, S4P 0W5