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| ID | Type | Description | Link |
|---|---|---|---|
| 218/12 revised | Other Identifier | CEIC |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir switch | Patients switched tenofovir to different antiretroviral regimen according to physicians decision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir switch | Other | Patients switched tenofovir to different antiretroviral regimen according to physicians decision |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks |
| Bone mineral density (BMD) changes |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral safety | Number (and percentage) and degree of adverse events, and percentage of therapy withdrawal, according to antiretroviral strategy after the change of tenofovir | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients in regular clinical and analytical follow up, receiving a tenofovir-containing regimen
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| Name | Affiliation | Role |
|---|---|---|
| Jose L Casado, MD | Asociacion para el Estudio de las Enfermedades Infecciosas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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
| 48 weeks |
| D052801 | Male Urogenital Diseases |