An observational study in Renal Toxicity, sponsored by Asociacion para el Estudio de las Enfermedades Infecciosas. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-09.
Sponsored by Asociacion para el Estudio de las Enfermedades Infecciosas · Observational
The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the effects of antiretroviral medication.
This is a retrospective cohort study involving 300 patients to determine the frequency of renal and bone comorbidities/toxicity in a large population of HIV-infected patients receiving antiretroviral therapy, in order to establish the differential role of classical factors, HIV infection, or antiretroviral therapy.
Asociacion para el Estudio de las Enfermedades Infecciosas is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV infected patients in active follow up, receiving antiretroviral therapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Incidence of Renal and Bone toxicity
Number and percentage of patients with: * Confirmed estimated glomerular filtration rate (eGFR) by CKD (chronic kidney disease)-epi equation decrease to \< 60 ml/min, or/and * More than 25% of eGFR decrease during therapy, or/and * Tubular toxicity defined as at least two of confirmed proteinuria (\> 300 mg/g), glycosuria with euglycemia, fractional excretion of urinary phosphate \> 20%, or of uric acid \> 10%. AND * Number and percentage of patients with bone mineral density (BMD) decrease \> 10% during follow up or progression to osteopenia (from normal) or to osteoporosis (from osteopenia)
Time frame: Patients will be evaluated for 2 years before
Consequences of renal or bone toxicity
Percentage of patients with regimen discontinuation (any drug in the regimen) because of renal or/and bone toxicity
Time frame: Patients will be evaluated for 2 years before
Changes in renal and bone toxicity
Evolution of renal and bone parameters in case of regimen discontinuation
Time frame: 2 years before entry
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asociacion para el Estudio de las Enfermedades Infecciosas