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

NCT ID: NCT02116751

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Renal Toxicity

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociacion para el Estudio de las Enfermedades Infecciosas

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose L Casado, MD

Role: PRINCIPAL_INVESTIGATOR

Ramon y Cajal Hospital

Locations

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Ramon y Cajal Hospital

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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EC 039/14

Identifier Type: -

Identifier Source: org_study_id