Clinical trial NCT00499187: Fanconi Syndrome Due to ARVs in HIV-Infected Persons
Official title: A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Fanconi Syndrome
Kidney Disease
Renal Impairment
Keywords: Fanconi
Kidney
Renal
HIV
HIV-1
Treatment Experienced
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected subjects with protocol defined Fanconi Syndrome

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Time to TDF discontinuation after diagnosis of Fanconi syndrome
timeFrame: Up to 48 weeks
measure: Time to confirmed resolution of Fanconi syndrome
timeFrame: Up to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
facility: University of Indiana
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Gilead Sciences
name: John Flaherty, PharmD
role: STUDY_DIRECTOR
References: