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Sponsored by: |
Gilead Sciences |
Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00499187 |
This is a cross-sectional cohort study of HIV+ subjects with protocol-defined Fanconi syndrome (confirmed CrCl decline and evidence of proximal tubulopathy), who are referred from multiple sites in the U.S. and Canada.
45 TDF Fanconi cases and 90 matched controls are planned for enrollment in this study. The number of non-TDF Fanconi cases is not pre-defined.
This study will evaluate risk factors for Fanconi Syndrome in HIV-infected persons receiving ARVs and consists of 3 substudies:
Substudy A - All Fanconi Cases
Describe the clinical characteristics of HIV-infected subjects who develop protocol-defined Fanconi syndrome irrespective of their antiretroviral (ARV) regimen.
Substudy B - Case Control Study of Tenofovir DF (TDF) Cases
Using a matched control cohort, explore risk factors for the development of Fanconi syndrome in subjects from Substudy A who are receiving TDF and have known baseline renal function. Each TDF case will be compared to two controls who are receiving TDF but who show no evidence of protocol defined Fanconi syndrome.
Substudy C - Prospective Follow-up of TDF Cases
In subjects from Substudy B who have protocol defined Fanconi syndrome, determine time to TDF discontinuation after diagnosis of Fanconi syndrome, and time to confirmed resolution will be determined.
Condition | Intervention | Phase |
HIV Infections Fanconi Syndrome Kidney Disease Renal Impairment |
Procedure: Blood Draws |
Phase IV |
MedlinePlus related topics: | AIDS |
Study Type: | Interventional |
Study Design: | Other, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons |
Estimated Enrollment: | 135 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Substudy A - All Fanconi Cases
Subjects with confirmed CrCl decline and evidence of proximal tubulopathy
Substudy B - Case Control Study of TDF Cases
For subjects from Substudy A who are receiving TDF and who have protocol-defined Fanconi syndrome (confirmed CrCl decline and evidence of proximal tubulopathy), their clinical characteristics will be characterized and compared to control subjects.
For each identified TDF case, two HIV-infected subjects (controls) from the same clinic, in a similar age category, and with no evidence of protocol-defined Fanconi syndrome while receiving TDF for a similar or longer duration, will be identified.
Substudy C - Prospective Follow-up of TDF Cases
Subjects from Substudy B who have Fanconi syndrome will be included in this substudy. Those subjects who continue on a TDF containing regimen will be followed for a maximum of 12 weeks, or until resolution of Fanconi syndrome, whichever occurs earlier. Subjects, who discontinue TDF prior to Week 12, will be followed for 48 weeks from date of discontinuation, or until resolution, whichever occurs earlier.
Resolution is defined as a confirmed return of CrCl to within 10% of the CrCl at the start of TDF as a component of the current ARV regimen. Confirmatory laboratory testing will be done within 14 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria - Fanconi Cases
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
Exclusion Criteria - Fanconi Cases
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
Inclusion Criteria - Controls
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
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.
Contact: John Flaherty | 650 522-5592 | john.flaherty@gilead.com |
United States, California | |||||
Recruiting | |||||
Los Angeles, California, United States, 90059 | |||||
United States, Colorado | |||||
Recruiting | |||||
Denver, Colorado, United States, 80220 | |||||
United States, Florida | |||||
Recruiting | |||||
Miami, Florida, United States, 33136 | |||||
United States, Georgia | |||||
Not yet recruiting | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, Indiana | |||||
Recruiting | |||||
Indianapolis, Indiana, United States, 46202 | |||||
United States, Maryland | |||||
Recruiting | |||||
Baltimore, Maryland, United States, 21205 | |||||
United States, Michigan | |||||
Recruiting | |||||
Detroit, Michigan, United States, 48202 | |||||
United States, New York | |||||
Recruiting | |||||
New York, New York, United States, 10029 | |||||
United States, Ohio | |||||
Recruiting | |||||
Cleveland, Ohio, United States, 44106 | |||||
United States, Texas | |||||
Recruiting | |||||
Houston, Texas, United States, 77004 | |||||
Canada, British Columbia | |||||
Recruiting | |||||
Vancouver, British Columbia, Canada, V6Z 1Y6 | |||||
Canada, Ontario | |||||
Not yet recruiting | |||||
Toronto, Ontario, Canada, M4N 3M5 | |||||
Canada, Quebec | |||||
Recruiting | |||||
Montreal, Quebec, Canada, H2L 2W5 |
Gilead Sciences |
Study Director: | John Flaherty, PharmD | Gilead Sciences |
Responsible Party: | Gilead Sciences ( John Flaherty, Director, Medical Affairs ) |
Study ID Numbers: | GS-US-104-0353 |
First Received: | July 9, 2007 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00499187 |
Health Authority: | United States: Institutional Review Board |
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