Fanconi Syndrome Due to ARVs in HIV-Infected Persons

Study Overview
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Brief Summary
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Cross-sectional cohort study of participants with HIV with or without protocol-defined Fanconi syndrome (confirmed creatinine clearance [CLcr] decline and evidence of proximal tubulopathy).

Official Title
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A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons

Conditions
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HIV Infections, Fanconi Syndrome, Kidney Disease, Renal Impairment

Intervention / Treatment
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* Procedure: Blood Draws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Fanconi Cases Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. Adult (greater than or equal to 18 years) HIV-1 infected subjects regardless of race or ethnicity. Subjects must be on a stable ARV regimen for greater than or equal to 1 month prior to study entry. Evidence of protocol-defined Fanconi syndrome TDF subjects must be on TDF-containing regimen at the time of onset of Fanconi syndrome. Negative serum pregnancy test (females of child-bearing potential only). Less than two years post-menopausal women of child-bearing potential (TDF subjects only) agree to follow an adequate birth control barrier method or agree to abstain from heterosexual intercourse while participating in the study. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. Exclusion Criteria - Fanconi Cases Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. Non TDF subjects who have received any TDF within the prior 6 months, or those who have received greater than 2 weeks cumulative treatment. TDF subjects who have previously served as a TDF control for this protocol. History of current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results. Inclusion Criteria - Controls Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. Adult (greater than or equal to 18 years) HIV-1 infected subjects regardless of race or ethnicity. No evidence of protocol-defined Fanconi syndrome On a TDF-containing regimen matched to a Fanconi case by clinic location, duration on TDF and age. Negative serum pregnancy test (females of child-bearing potential only). The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. Exclusion Criteria - Controls Subjects who meet the following exclusion criteria are not to be enrolled in this study. • History of current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fanconi Cases<br>This cohort enrolled participants with evidence of protocol-defined Fanconi syndrome (confirmed creatinine clearance decline and evidence of proximal tubulopathy). | Procedure: Blood Draws<br>* A single whole blood sample was collected for genomic analysis.<br>|
| Control Cases<br>This cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome. | Procedure: Blood Draws<br>* A single whole blood sample was collected for genomic analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to TDF discontinuation after diagnosis of Fanconi syndrome |  | Up to 48 weeks | 
| Time to confirmed resolution of Fanconi syndrome |  | Up to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fanconi, Kidney, Renal, HIV, HIV-1, Treatment Experienced