Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies
TDFOUT
A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy
2 other identifiers
observational
245
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 2, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 30, 2015
December 1, 2015
1.4 years
August 2, 2014
December 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Antiviral efficacy
48 weeks
Bone mineral density (BMD) changes
48 weeks
Other Outcomes (1)
Antiviral safety
48 weeks
Study Arms (1)
Tenofovir switch
Patients switched tenofovir to different antiretroviral regimen according to physicians decision
Interventions
Patients switched tenofovir to different antiretroviral regimen according to physicians decision
Eligibility Criteria
HIV-infected patients in regular clinical and analytical follow up, receiving a tenofovir-containing regimen
You may qualify if:
- HIV-infected patients
- Older than 18 years
- Receiving a Tenofovir-containing regimen, and with criteria of renal toxicity (see above)
- Switching the antiretroviral regimen
You may not qualify if:
- Pregnancy
- Patients receiving prolonged therapy with other nephrotoxic drugs
- Patients not receiving or interrupting antiretroviral regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ramon y Cajal
Madrid, 28034, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose L Casado, MD
Asociacion para el Estudio de las Enfermedades Infecciosas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Investigator
Study Record Dates
First Submitted
August 2, 2014
First Posted
August 6, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 30, 2015
Record last verified: 2015-12