Phase
Condition
Obesity
Hiv
Treatment
DOR/3TC/TDF
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 yearand less than 5 years prior to screening
Significant weight gain since initiation of the INSTI-based regimen (>10% ofbaseline body weight)
Viral load of <200 copies/mL for > 6 consecutive months prior to screening (singleviral blips <200 copies/mL accepted if re-suppressed)
Documentation of weight, glycemia, cholesterol, and blood pressure (BP) historywithin 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
Exclusion Criteria:
Pregnancy or desire to become pregnant within the next year
Failure to use adequate contraception during the study if of child-bearingpotential.
Any underlying documented ART resistance to doravirine, tenofovir disoproxilfumarate, 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
Study Design
Study Description
Connect with a study center
University Health Network
Toronto, Ontario M5G2C4
CanadaSite Not Available
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