Clinical trial NCT02209740: Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies
Official title: A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Disease
Keywords: renal toxicity, HIV, antiretroviral, outcome
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2014-08-06
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients in regular clinical and analytical follow up, receiving a tenofovir-containing regimen

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Renal outcome
timeFrame: 48 weeks
Secondary outcomes:
measure: Antiviral efficacy
timeFrame: 48 weeks
measure: Bone mineral density (BMD) changes
timeFrame: 48 weeks
Other outcomes:
measure: Antiviral safety
timeFrame: 48 weeks
Locations:
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
Study officials:
affiliation: Asociacion para el Estudio de las Enfermedades Infecciosas
name: Jose L Casado, MD
role: PRINCIPAL_INVESTIGATOR
References: