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

July 9, 2007
March 14, 2014
September 2007
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
This study is descriptive in nature and does not evaluate safety and efficacy of treatment.
Complete list of historical versions of study NCT00499187 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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).

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

HIV infected subjects with protocol defined Fanconi Syndrome

  • HIV Infections
  • Fanconi Syndrome
  • Kidney Disease
  • Renal Impairment
Procedure: Blood Draws
A single whole blood sample was collected for genomic analysis.
  • Fanconi Cases
    This cohort enrolled participants with evidence of protocol-defined Fanconi syndrome (confirmed creatinine clearance decline and evidence of proximal tubulopathy).
    Intervention: Procedure: Blood Draws
  • Control Cases
    This cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome.
    Intervention: Procedure: Blood Draws
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2011
March 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00499187
GS-US-104-0353
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: John Flaherty, PharmD Gilead Sciences
Gilead Sciences
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP