Status:
TERMINATED
Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF?
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Merck Canada Inc.
Conditions:
Hiv
Weight Gain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Weight gain with the integrase inhibitors and tenofovir alafenamide has been observed in observational cohorts and randomized controlled clinical trials. Although some risk factors have been identifie...
Detailed Description
Background and Importance: Lifelong antiretroviral treatment (ART) is recommended for all people living with HIV (PLWH) primarily with integrase strand inhibitor (INSTI)-based regimens. While weight g...
Eligibility Criteria
Inclusion
- Documented HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider; OR HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL; OR any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid Multispot antibody differentiation assay.
- On an Integrase Strand Transfer Inhibitor (INSTI) based regimen for at least 1 year and less than 5 years prior to screening
- Significant weight gain since initiation of the INSTI-based regimen (\>10% of baseline body weight)
- Viral load of \<200 copies/mL for \> 6 consecutive months prior to screening (single viral blips \<200 copies/mL accepted if re-suppressed)
- Documentation of weight, glycemia, cholesterol, and blood pressure (BP) history within the last year.
- Signed Informed Consent Form (Appendix B) and willing to comply with the protocol.
- Using proper contraception if of child bearing age and potential.
Exclusion
- Pregnancy or desire to become pregnant within the next year
- Failure to use adequate contraception during the study if of child-bearing potential.
- Any underlying documented ART resistance to doravirine, tenofovir disoproxil fumarate, or lamivudine
- Prior virologic failure
- Concomitant drugs that interact with doravirine
- Initiated on concomitant drugs known to cause weight gain within the last 6 months (i.e. antidepressants and antipsychotics)
- Concomitant drugs known to cause nephrotoxicity
- History of renal toxicity or renal events while on TDF therapy.
- Creatinine clearance (CrCL) \< 50 mL/min
- Inability to read/understand English
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04665375
Start Date
April 26 2021
End Date
March 31 2024
Last Update
July 16 2025
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G2C4