Skip to content

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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221117001
Enrollment
268
Registered
2022-11-17
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virologically suppressed HIV On TDF/FTC/EFV CrCl more than 60 ml/min Dual antiretroviral therapy, dolutegravir, virologic outcome, renal outcome

Interventions

Oral dolutegravir 50 mg per day plus lamivudine 300 mg per day,Oral fixed drug combination of TDF 300 mg per day, lamivudine 300 mg per day, and dolutegravir 50 mg per day
Active Comparator Drug,Active Comparator Drug
DTG/3TC,TDF/3TC/DTG

Sponsors

Mahasarakham University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate 24, 48 weeks ml/min/1.73 m2

Secondary

MeasureTime frame
HIV viral load 24, 48 weeks copies per mL

Countries

Thailand

Contacts

Public ContactSamadhi Patamatamkul

Faculty of Medicine, Mahasarakham University

samadhi.p@msu.ac.th66815441374

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026