HIV Infections Clinical Trial
Official title:
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).
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | March 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Indiana | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to TDF discontinuation after diagnosis of Fanconi syndrome | Up to 48 weeks | No | |
| Primary | Time to confirmed resolution of Fanconi syndrome | Up to 48 weeks | No |
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