Fanconi Syndrome Due to ARVs in HIV-Infected Persons

NCT00499187 | Completed

• 1 other identifier: GS-US-104-0353
• Study Type: observational
• Target: 56
• Locations: 2 countries
• Sites: 13

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).

Conditions

HIV Infections; Fanconi Syndrome; Kidney Disease; Renal Impairment

Keywords

Fanconi; Kidney; Renal; HIV; HIV-1; Treatment Experienced

Outcome Measures

Primary Outcomes (2)

• Time to TDF discontinuation after diagnosis of Fanconi syndrome

  Up to 48 weeks

• Time to confirmed resolution of Fanconi syndrome

  Up to 48 weeks

Study Arms (2)

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

Control Cases

This cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome.

Procedure: Blood Draws

Interventions

Blood Draws PROCEDURE

A single whole blood sample was collected for genomic analysis.

Control Cases; Fanconi Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected subjects with protocol defined Fanconi Syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• History of current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (13)

Unknown Facility

Los Angeles, California, 90059, United States

Location

Unknown Facility

Denver, Colorado, 80220, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

Baltimore, Maryland, 21205, United States

Location

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Unknown Facility

Toronto, Ontario, M4N 3M5, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 2W5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

HIV Infections; Fanconi Syndrome; Kidney Diseases; Renal Insufficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Flaherty, PharmD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (3); US (10)