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Virological response of switching tenofovir disoproxil fumarate(TDF)-based regimen to abacavir(ABC)-based regimen versus lopinavir/ritonavir(LPV/r) plus lamivudine(3TC) in HIV-infected patients with TDF-induced nephrotoxicity at 24 weeks: a prospective, open-label, randomized controlled trial

Virological response of switching tenofovir disoproxil fumarate(TDF)-based regimen to abacavir(ABC)-based regimen versus lopinavir/ritonavir(LPV/r) plus lamivudine(3TC) in HIV-infected patients with TDF-induced nephrotoxicity at 24 weeks : a prospect

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190708002
Enrollment
84
Registered
2019-07-08
Start date
2018-09-06
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

Tenofovir disoproxil fumarate (TDF)&#45

Interventions

Kivexa ® (ABC/3TC&#44
600/300) 1 tab PO OD combined with efavirenz (EFV&#44
600) 1 tab PO OD (ABC based regimen), Kaletra® (LPV/r&#44
200/50) 2 tabs PO q 12 hr&#44
OR Aluvia® (LPV/r&#44
100/25) 4 tabs PO q 12 hr combined with lamivudine (3TC&#44
150) 1 tab PO q 12 hr
Active Comparator Drug,Active Comparator Drug
ABC&#45
based regimen ,LPV/r+3TC

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age >18 years - HIV-infected Patients - Receiving TDF-based regimen - Virologic control (VL 10% from baseline after TDF treatment - HLA B*5701=negative

Exclusion criteria

Exclusion criteria: - Pregnancy - HBV infection(Positive for HBS Ag) - TB or active opportunistic infection - Cirrhosis Child-Pugh score B-C - Preexisting kidney disease(chronic kidney disease, ureteric stone, urinary tract obstruction)

Design outcomes

Primary

MeasureTime frame
Virological response 24 weeks HIV Viral load—

Secondary

MeasureTime frame
Immunologic response 24 weeks CD4 change,eGFR 24 weeks eGFR change,Proximal tubular function 24 weeks FEPO4, TmP/GFR, FEUA, UPCR, ,Lipid profiles 24 weeks Total cholesterl, Triglycerides, HDL, LDL—

Countries

Thailand

Contacts

Public ContactNopporn Songumpai
zea_me@hotmail.com0819906064

Outcome results

None listed

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