Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients

Completed

• Conditions: Renal Toxicity

• Registration Number: NCT02116751
• Lead Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-06
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Confirmed HIV infection

Exclusion Criteria

• Pregnancy
• Prior therapy with antineoplastic chemotherapy or chronic treatment with corticosteroids
• Previous chronic therapy with antiresorptive bone therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Renal and Bone toxicity	Patients will be evaluated for 2 years before	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)

Secondary Outcome Measures

Name	Time	Method
Consequences of renal or bone toxicity	Patients will be evaluated for 2 years before	Percentage of patients with regimen discontinuation (any drug in the regimen) because of renal or/and bone toxicity

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain