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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02116751

Acronym

ComorVIH

Enrollment

306

Registered

2014-04-17

Start date

2014-04-30

Completion date

2014-12-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Toxicity

Keywords

HIV, antiretroviral, toxicity, eGFR, tubular disease, BMD

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

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

Countries

Spain

Outcome results