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Clinical Trials/TCTR20221117001
TCTR20221117001
Not yet recruiting
Phase 3

A randomized controlled trial evaluating virologic and renal outcomes after switching from TDF/FTC/EFV to TDF/3TC/DTG (TLD) versus DTG/3TC in virologically suppressed Thai PWH

Mahasarakham University0 sites268 target enrollmentNovember 17, 2022

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Virologically suppressed HIVOn TDF/FTC/EFVCrCl more than 60 ml/min
Sponsor
Mahasarakham University
Enrollment
268
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 17, 2022
End Date
March 1, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • HIV\-infected adults age of 18 years or more
  • Receiving TDF/FTC/EFV
  • Documented HIV VL \< 50 copies/mL in the past 12 months

Exclusion Criteria

  • History of documented HIV drug resistance
  • History of DTG hypersensitivity
  • Estimated glomerular filtration rate \< 60 ml/min
  • Cirrhosis CTP B or C
  • Currently on antituberculosis therapy
  • Receiving metformin \> 1000 mg/day
  • If available, initial HIV VL \> 500,000 copies/mL
  • Positive HBsAg

Outcomes

Primary Outcomes

Not specified

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