Fanconi Syndrome Due to ARVs in HIV-Infected Persons (NCT00499187) | Clinical Trial Compass
CompletedNot Applicable
Fanconi Syndrome Due to ARVs in HIV-Infected Persons
United States56 participantsStarted 2007-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Time to TDF discontinuation after diagnosis of Fanconi syndrome