Fanconi Syndrome, HIV Infections, Kidney Disease, Renal Impairment
Conditions
Keywords
Fanconi, Kidney, Renal, HIV, HIV-1, Treatment Experienced
Brief summary
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).
Interventions
PROCEDUREBlood Draws
A single whole blood sample was collected for genomic analysis.
Sponsors
Gilead Sciences
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to confirmed resolution of Fanconi syndrome | Up to 48 weeks |
| Time to TDF discontinuation after diagnosis of Fanconi syndrome | Up to 48 weeks |
Countries
Canada, United States
Outcome results
None listed