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Fanconi Syndrome Due to ARVs in HIV-Infected Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00499187
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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).

Condition or disease Intervention/treatment
HIV Infections Fanconi Syndrome Kidney Disease Renal Impairment Procedure: Blood Draws

Study Design
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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons
Study Start Date : September 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to TDF discontinuation after diagnosis of Fanconi syndrome [ Time Frame: Up to 48 weeks ]
  2. Time to confirmed resolution of Fanconi syndrome [ Time Frame: Up to 48 weeks ]

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infected subjects with protocol defined Fanconi Syndrome
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499187


Locations
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United States, California
Los Angeles, California, United States, 90059
United States, Colorado
Denver, Colorado, United States, 80220
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Indiana
University of Indiana
Indianapolis, Indiana, United States, 46202
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Michigan
Detroit, Michigan, United States, 48202
United States, New York
New York, New York, United States, 10029
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Texas
Houston, Texas, United States, 77004
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H2L 2W5
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: John Flaherty, PharmD Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00499187    
Other Study ID Numbers: GS-US-104-0353
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Keywords provided by Gilead Sciences:
Fanconi
Kidney
Renal
 HIV
HIV-1
Treatment Experienced
Additional relevant MeSH terms:
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Fanconi Syndrome
Fanconi Anemia
Kidney Diseases
Renal Insufficiency
Syndrome
Disease
Pathologic Processes
Urologic Diseases
Renal Tubular Transport, Inborn Errors
Genetic Diseases, Inborn
 Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Anemia
Hematologic Diseases
Congenital Bone Marrow Failure Syndromes
Bone Marrow Failure Disorders
Bone Marrow Diseases
DNA Repair-Deficiency Disorders
Metabolic Diseases