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Completed

NCT Number: NCT02116751

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

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.

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Key information

Conditions

Renal Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramon y Cajal Hospital

Madrid, 28034, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Renal and Bone toxicity

    Time frame: 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 outcomes

  1. Consequences of renal or bone toxicity

    Time frame: 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 outcomes

  1. Changes in renal and bone toxicity

    Time frame: 2 years before entry

    Evolution of renal and bone parameters in case of regimen discontinuation

Sponsors and collaborators

Lead sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Network

Registry information

Official study title

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

Acronym: ComorVIH

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2014
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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