Renal DiseaseTDFOUTNCT02209740
Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies
An observational study of Renal Disease, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- What is being tested?
- Tenofovir switch
- How many people
- 245 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients in regular clinical and analytical follow up, receiving a tenofovir-containing regimen
Who may be able to join
- HIV-infected patients
- Older than 18 years
- Receiving a Tenofovir-containing regimen, and with criteria of renal toxicity (see above)
- Switching the antiretroviral regimen
Who cannot join
- Pregnancy
- Patients receiving prolonged therapy with other nephrotoxic drugs
- Patients not receiving or interrupting antiretroviral regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy
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.
Read the 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).
- Conditions
- Renal Disease
- Being tested
- Tenofovir switch
- Keywords
- renal toxicity, HIV, antiretroviral, outcome
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir switchOther
Patients switched tenofovir to different antiretroviral regimen according to physicians decision
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir switch | Patients switched tenofovir to different antiretroviral regimen according to physicians decision Receives: Other: Tenofovir switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (2)
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
Measured: 48 weeks
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
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas
- Investigators
- Jose L Casado, MD, Principal investigator, Asociacion para el Estudio de las Enfermedades Infecciosas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209740
- Sponsor's protocol ID
- TDFOUT
- Other IDs
- 218/12 revised
- Acronym
- TDFOUT
- Status last verified
- Dec 2015
- First submitted
- 2 Aug 2014
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy
- ClinicalTrials.gov ID
- NCT02209740
- Acronym / sponsor ID
- TDFOUT / TDFOUT
- Conditions
- Renal Disease
- Keywords
- renal toxicity, HIV, antiretroviral, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades InfecciosasResearch network
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenofovir switch | – | Other: Tenofovir switchPatients switched tenofovir to different antiretroviral regimen according to physicians decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients in regular clinical and analytical follow up, receiving a tenofovir-containing regimen
Key inclusion criteria (4 listed)
- HIV-infected patients
- Older than 18 years
- Receiving a Tenofovir-containing regimen, and with criteria of renal toxicity (see above)
- Switching the antiretroviral regimen
Key exclusion criteria (3 listed)
- Pregnancy
- Patients receiving prolonged therapy with other nephrotoxic drugs
- Patients not receiving or interrupting antiretroviral regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir switchPatients switched tenofovir to different antiretroviral regimen according to physicians decision | Other | Tenofovir switch |
Primary outcome
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
2 secondary outcomes
Antiviral efficacy
Time frame: 48 weeks
Bone mineral density (BMD) changes
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Casado, MD principal investigator
Asociacion para el Estudio de las Enfermedades Infecciosas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal outcome (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.