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

Renal Toxicity Clinical Trial

— ComorVIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116751
• Other study ID #: EC 039/14
• Status: Completed
• Phase: N/A
• First received: April 11, 2014
• Last updated: December 6, 2014
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Renal Toxicity

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in renal and bone toxicity	Evolution of renal and bone parameters in case of regimen discontinuation	2 years before entry	Yes
Primary	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	Yes
Secondary	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	Yes