Renal Toxicity Clinical Trial
— ComorVIHOfficial title:
Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy
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.
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Spain | Ramon y Cajal Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Asociacion para el Estudio de las Enfermedades Infecciosas |
Spain,
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 |
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