Fanconi Syndrome Due to ARVs in HIV-Infected Persons

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

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-03-31

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).

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Detailed Description

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Conditions

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HIV Infections Fanconi Syndrome Kidney Disease Renal Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fanconi Cases

This cohort enrolled participants with evidence of protocol-defined Fanconi syndrome (confirmed creatinine clearance decline and evidence of proximal tubulopathy).

Blood Draws

Intervention Type PROCEDURE

A single whole blood sample was collected for genomic analysis.

Control Cases

This cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome.

Blood Draws

Intervention Type PROCEDURE

A single whole blood sample was collected for genomic analysis.

Interventions

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Blood Draws

A single whole blood sample was collected for genomic analysis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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.

• History of current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No