Fanconi Syndrome Due to ARVs in HIV-Infected Persons

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

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections; Renal Impairment; Fanconi Syndrome; Kidney Disease
• Intervention / Treatment: Procedure: Blood Draws

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
  • Quebec
    • Montreal, Quebec, Canada, H2L 2W5
• United States
  • California
    • Los Angeles, California, United States, 90059
  • Colorado
    • Denver, Colorado, United States, 80220
  • Florida
    • Miami, Florida, United States, 33136
  • Georgia
    • Atlanta, Georgia, United States, 30308
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • University of Indiana
  • Maryland
    • Baltimore, Maryland, United States, 21205
  • Michigan
    • Detroit, Michigan, United States, 48202
  • New York
    • New York, New York, United States, 10029
  • Ohio
    • Cleveland, Ohio, United States, 44106
  • Texas
    • Houston, Texas, United States, 77004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV infected subjects with protocol defined Fanconi Syndrome

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fanconi Cases; This cohort enrolled participants with evidence of protocol-defined Fanconi syndrome (confirmed creatinine clearance decline and evidence of proximal tubulopathy).	Procedure: Blood Draws; A single whole blood sample was collected for genomic analysis.
Control Cases; This cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome.	Procedure: Blood Draws; A single whole blood sample was collected for genomic analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to TDF discontinuation after diagnosis of Fanconi syndrome	Up to 48 weeks
Time to confirmed resolution of Fanconi syndrome	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: July 9, 2007
• First Submitted That Met QC Criteria: July 9, 2007
• First Posted (ESTIMATE): July 11, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2014
• Last Update Submitted That Met QC Criteria: March 14, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: HIV; HIV-1; Treatment Experienced; Kidney; Renal; Fanconi
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease; Bone Marrow Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; DNA Repair-Deficiency Disorders; Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Renal Tubular Transport, Inborn Errors; Syndrome; Kidney Diseases; Renal Insufficiency; Fanconi Syndrome; Fanconi Anemia
• Other Study ID Numbers: GS-US-104-0353