Fanconi Syndrome Due to ARVs in HIV-Infected Persons

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499187
• Other study ID #: GS-US-104-0353
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2007
• Last updated: March 14, 2014
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fanconi Anemia
• Fanconi Syndrome
• HIV Infections
• Kidney Disease
• Kidney Diseases
• Renal Impairment
• Renal Insufficiency
• Syndrome

Intervention

Procedure:
• Blood Draws
A single whole blood sample was collected for genomic analysis.

Locations

Country	Name	City	State
United States	University of Indiana	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to TDF discontinuation after diagnosis of Fanconi syndrome		Up to 48 weeks	No
Primary	Time to confirmed resolution of Fanconi syndrome		Up to 48 weeks	No