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Completed

NCT Number: NCT00499187

Fanconi Syndrome Due to ARVs 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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fanconi Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Kidney Disease Kidney Diseases Lentivirus Infections Male Urogenital Diseases RNA Virus Infections Renal Impairment Renal Insufficiency Renal Tubular Transport, Inborn Errors Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draws

Procedure

A single whole blood sample was collected for genomic analysis.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2007
Registry last updated
Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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