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

Phase 3

• Conditions: Virologically suppressed HIVOn TDF/FTC/EFVCrCl more than 60 ml/min; Dual antiretroviral therapy, dolutegravir, virologic outcome, renal outcome

• Registration Number: TCTR20221117001
• Lead Sponsor: Mahasarakham University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-17
• Study Completion: 2024-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 268

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

Pregnancy
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate 24, 48 weeks ml/min/1.73 m2

Secondary Outcome Measures

Name	Time	Method
HIV viral load 24, 48 weeks copies per m