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

Phase 3

Completed

• Conditions: Tenofovir disoproxil fumarate (TDF)- induced nephrotoxicity in HIV infected patients; TDF induced nephrotoxicity, switching, virological response, abacavir, lopinavir/ritonavir

• Registration Number: TCTR20190708002
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-02-28
• Study Start: 2019-07-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

- Age >18 years
- HIV-infected Patients
- Receiving TDF-based regimen
- Virologic control (VL < 40 copies for at least 6 months)
- TDF induced proximal renal tubular dysfunction (PRTD) or decline in eGFR of >10% from baseline after TDF treatment
- HLA B*5701=negative

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virological response 24 weeks HIV Viral load

Secondary Outcome Measures

Name	Time	Method
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, LD