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Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies — TDFOUT  

Renal Disease Clinical Trial

Official title:
A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy

Clinical Trial Summary

Renal outcome could be different after switching tenofovir to different antiretroviral strategies, in case of renal toxicity. Therefore, it is necessary to evaluate the importance of renal evolution in these patients, in terms of grade and time to renal improvement, according to the different options after interrupting tenofovir. The aim of this study was to explore the renal outcome after tenofovir according to new antiretroviral regimen.

Clinical Trial Description

Renal toxicity has become an important issue in a large number of HIV infected patients receiving a tenofovir-containing regimen. However, there are no data about the best antiretroviral regimen in patients switching tenofovir because of renal toxicity, in time, grade or persistence of renal improvement. Thus, patients with renal toxicity on tenofovir, defined as:

- a progressive decrease of at least 25% of estimated glomerular filtration rate (GFR, by chronic kidney disease-epi equation), or

- confirmed value of GFR below 60 ml/min in two successive determinations, or

- proximal tubular renal dysfunction, as indicated by the presence of at least 3 of the following parameters: proteinuria> 150 mg/g; excretion fractional of phosphorus in urine > 20%; glucosuria > 150 mg; or/and tubular proteinuria/albuminuria ratio above 0.4.

who changed to the combination of abacavir plus a third drug, or to a nucleoside analogues-free antiretroviral combination (dual therapy, monotherapy) will be followed for 1 year to establish the time and grade of improvement (defined as the lack of above criteria). ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02209740
Study type Observational
Source Asociacion para el Estudio de las Enfermedades Infecciosas
Contact
Status Completed
Phase N/A
Start date July 2014
Completion date December 2015
View Details
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