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Completed

NCT Number: NCT02209740

Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Ramon y Cajal

Madrid, 28034, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir switch

Other

Patients switched tenofovir to different antiretroviral regimen according to physicians decision

Primary outcomes

  1. Renal outcome

    Time frame: 48 weeks

    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

Secondary outcomes

  1. Antiviral efficacy

    Time frame: 48 weeks

    Number of patients without virological failure, defined as an HIV RNA level above 37 copies/ml, 48 weeks after the change of tenofovir

  2. Bone mineral density (BMD) changes

    Time frame: 48 weeks

    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

Other outcomes

  1. Antiviral safety

    Time frame: 48 weeks

    Number (and percentage) and degree of adverse events, and percentage of therapy withdrawal, according to antiretroviral strategy after the change of tenofovir

Sponsors and collaborators

Lead sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Network

Registry information

Official study title

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

Acronym: TDFOUT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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