Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies

Renal Disease Clinical Trial

— TDFOUT  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02209740
• Other study ID #: TDFOUT
• Secondary ID: 218/12 revised
• Status: Completed
• Phase: N/A
• First received: August 2, 2014
• Last updated: December 28, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Disease

Intervention

Other:
• Tenofovir switch
Patients switched tenofovir to different antiretroviral regimen according to physicians decision

Locations

Country	Name	City	State
Spain	Hospital Ramon y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antiviral safety	Number (and percentage) and degree of adverse events, and percentage of therapy withdrawal, according to antiretroviral strategy after the change of tenofovir	48 weeks	Yes
Primary	Renal outcome	Evolution of renal parameters after switching tenofovir according to antiretroviral drug or regimen used, in terms of GFR (glomerular filtration rate by Chronic Kidney Disease-epidemiological collaboration equation) improvement, increase in excretion fractional of phosphorus in urine, decrease in proteinuria, and in glycosuria. As control group, renal outcome will be evaluated in patients continuing TDF-based therapy	48 weeks	Yes
Secondary	Antiviral efficacy	Number of patients without virological failure, defined as an HIV RNA level above 37 copies/ml, 48 weeks after the change of tenofovir	48 weeks	No
Secondary	Bone mineral density (BMD) changes	Changes in BMD in the subgroup of patients with two successive BMD measurements, before and after TDF switch, according to baseline risk factors for BMD change (age, body mass index, hypovitaminosis D, secondary hyperparathyroidism), in comparison with patients continuing TDF	48 weeks	No