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

Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy

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.

Study Overview

• Status: Completed
• Conditions: Renal Toxicity

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 Type: Observational
• Enrollment (Actual): 306

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Ramón y Cajal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients in active follow up, receiving antiretroviral therapy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in renal and bone toxicity	Evolution of renal and bone parameters in case of regimen discontinuation	2 years before entry

Collaborators and Investigators

• Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
• Investigators: Principal Investigator: Jose L Casado, MD, Ramón y Cajal Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 6, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: HIV, antiretroviral, toxicity, eGFR, tubular disease, BMD
• Other Study ID Numbers: EC 039/14