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

NCT02116751 | Completed

• 1 other identifier: EC 039/14
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Toxicity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Consequences of renal or bone toxicity

  Patients will be evaluated for 2 years before

Other Outcomes (1)

• Changes in renal and bone toxicity

  2 years before entry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients in active follow up, receiving antiretroviral therapy

You may qualify if:

• Confirmed HIV infection

You may not qualify if:

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

Sponsors & Collaborators

• Asociacion para el Estudio de las Enfermedades Infecciosas: lead

Study Sites (1)

Ramon y Cajal Hospital

Madrid, Madrid, 28034, Spain

Location

Study Officials

• Jose L Casado, MD

  Ramon y Cajal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 17, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-04

Locations

ES (1)