About The Study
The aim of this cohort study is to evaluate risk factors for Fanconi syndrome— kidney malfunction— in HIV-positive adults on antiretroviral (ARV) treatment, including tenofovir DF (TDF). To be eligible for this study, participants must be on a stable ARV regimen for at least one month prior to study entry, have protocol-defined Fanconi syndrome, and TDF subjects must be on TDF-containing regimen at the time of onset of Fanconi syndrome. This study is recruiting 135 participants (cases and controls inclusive) in the U.S. and Canada.
There are three substudies:
- Substudy A will describe the clinical characteristics of HIV-infected participants who develop protocol-defined Fanconi syndrome irrespective of their ARV regimen.
- Substudy B will use a matched control cohort and explore risk factors for the development of Fanconi syndrome in participants from Substudy A who are receiving Tenofovir DF (TDF) and have known baseline renal function.
- Substudy C will follow TDF Cases in participants from Substudy B, who have protocol-defined Fanconi syndrome, for up to 12 weeks (for those who remain on TDF), up to 48 weeks (for those who discontinue TDF and do not show resolution), or until resolution of Fanconi syndrome.
Study Approach
This trial is also listed on Clinicaltrials.gov
Eligibility Requirements
Required
Fanconi Cases:
- Be 18 years or older
- HIV-positive
- Be on a stable ARV regimen for at least 1 month prior to study entry
- Evidence of protocol-defined Fanconi syndrome
- TDF participants must be on TDF-containing regimen at the time of Fanconi syndrome onset
- Negative pregnancy test (females of child-bearing potential only)
- Women of child-bearing potential (TDF subjects only) must agree to follow an adequate birth control barrier method or agree to abstain from heterosexual intercourse while participating in the study
- Willing to abstain from substances which may alter plasma study drug levels by interaction with the cytochrome P450 system during the study
- Sign informed consent form
Controls:
- Be 18 years or older
- HIV-1 infected
- 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 pregnancy test
- Sign an informed consent form
Not Allowed
Fanconi Cases:
- Non-TDF participants – any TDF within 6 months prior to study onset, and more than 2 weeks of cumulative treatment
- Have previously served as a TDF control for this study
- History of alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results
Controls:
- History of alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results