Outcome of early switching of Tenofovir Disoproxil Fumarate (TDF) in HIV-infected patients with TDF-induced nephrotoxicity: a prospective study

Phase 3

Recruiting

• Conditions: TDF- induced proximal renal tubulopathy; Complete recovery; HIV

• Registration Number: TCTR20190307003
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Study Completion: 2019-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

HIV-infected adult age of 18 years old or more plus the followings:
1) on TDF-containing regimen
2) no documented HIV drug resistance
3) evidence of proximal renal tubulopathy (PRT)
4) protease inhibitor-naïve patients

Exclusion Criteria

1) any concomitant kidney disease or abnormal urinary sediments before TDF initiation
2) nephrotoxic agents or MRP-4 inhibitors use in the previous 28 days prior to recruitment
3) pregnant patients
4) documented obstructive uropathy including BPH and stones
5) SGLT-2 inhibitors use.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete recovery of proximal tubular markers 1 year Tubular markers

Secondary Outcome Measures

Name	Time	Method
Virological outcome 1 year HIV viral load