Fanconi Syndrome Due to ARVs in HIV-Infected Persons
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons |
- This study is descriptive in nature. PE including VS, AEs, chemistry profile, U/A, hematology, CD4, HIV-1 RNA, pregnancy test,creatinine clearance using Cockcroft Gault formula and GFR calculated using the abbreviated MDRD formula. [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 135 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
-
Procedure: Blood Draws
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.
Eligibility| 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.
- 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| 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 | |
| Study Director: | John Flaherty, PharmD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | John Flaherty, Director, Medical Affairs, 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: | May 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
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 March 10, 2013
