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Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies

NCT ID: NCT02209740

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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).

Conditions

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Renal Disease

Keywords

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renal toxicity, HIV, antiretroviral, outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tenofovir switch

Patients switched tenofovir to different antiretroviral regimen according to physicians decision

Tenofovir switch

Intervention Type OTHER

Patients switched tenofovir to different antiretroviral regimen according to physicians decision

Interventions

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Tenofovir switch

Patients switched tenofovir to different antiretroviral regimen according to physicians decision

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociacion para el Estudio de las Enfermedades Infecciosas

NETWORK

Sponsor Role lead

Responsible Party

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Jose L. Casado

Clinical Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose L Casado, MD

Role: PRINCIPAL_INVESTIGATOR

Asociacion para el Estudio de las Enfermedades Infecciosas

Locations

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Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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218/12 revised

Identifier Type: OTHER

Identifier Source: secondary_id

TDFOUT

Identifier Type: -

Identifier Source: org_study_id