Trial record 5 of 27 for:    " June 13, 2007":" July 13, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Fanconi Syndrome Due to ARVs in HIV-Infected Persons

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00499187
First received: July 9, 2007
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
HIV Infections
Fanconi Syndrome
Kidney Disease
Renal Impairment
Procedure: Blood Draws
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Time to TDF discontinuation after diagnosis of Fanconi syndrome [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  • Time to confirmed resolution of Fanconi syndrome [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 56
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499187

Locations
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
Study Director: John Flaherty, PharmD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00499187     History of Changes
Other Study ID Numbers: GS-US-104-0353
Study First Received: July 9, 2007
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Gilead Sciences:
Fanconi
Kidney
Renal
HIV
HIV-1
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Fanconi Syndrome
Fanconi Anemia
Kidney Diseases
Renal Insufficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Urologic Diseases
Renal Tubular Transport, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Anemia
Hematologic Diseases
Bone Marrow Diseases
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on April 21, 2014