NCT02116751|Completed
Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients
ComorVIH
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ComorVIH
Sponsor study identifier
observational
306
1 country
1
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 11, 2014
Actual (reported)April 17, 2014
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)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)
Patients will be evaluated for 2 years before
Consequences of renal or bone toxicity
Patients will be evaluated for 2 years before
Changes in renal and bone toxicity
2 years before entry
HIV infected patients in active follow up, receiving antiretroviral therapy
Ramon y Cajal Hospital
Madrid, Madrid, 28034, Spain
Jose L Casado, MD
Ramon y Cajal Hospital
306 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2014
First Posted
April 17, 2014
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
December 9, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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