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

Asociacion para el Estudio de las Enfermedades Infecciosas

Status: Completed

Conditions: Renal Disease

Treatments: Other: Tenofovir switch

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02209740

218/12 revised (Other Identifier)

TDFOUT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-infected patients
• Older than 18 years
• Receiving a Tenofovir-containing regimen, and with criteria of renal toxicity (see above)
• Switching the antiretroviral regimen

Exclusion criteria

• Pregnancy
• Patients receiving prolonged therapy with other nephrotoxic drugs
• Patients not receiving or interrupting antiretroviral regimen

Trial design

245 participants in 1 patient group

Tenofovir switch

Description:

Patients switched tenofovir to different antiretroviral regimen according to physicians decision

Treatment:

Other: Tenofovir switch