HIV InfectionsNCT00499187
Fanconi Syndrome Due to ARVs in HIV-Infected Persons
An observational study of HIV Infections and Fanconi Syndrome, run by Gilead Sciences at 13 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Fanconi Syndrome, Kidney Disease
- What is being tested?
- Blood Draws
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2007to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected subjects with protocol defined Fanconi Syndrome
Who may be able to join
- 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).
Show all 14Show fewer
- 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.
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Study site
Atlanta, Georgia, 30308
Study site
Baltimore, Maryland, 21205
Study site
Cleveland, Ohio, 44106
Study site
Denver, Colorado, 80220
Study site
Detroit, Michigan, 48202
Study site
Houston, Texas, 77004
University of Indiana
Indianapolis, Indiana, 46202
Study site
Los Angeles, California, 90059
Study site
Miami, Florida, 33136
Study site
New York, New York, 10029
Canada3 sites
Study site
Montreal, Quebec, H2L 2W5
Study site
Toronto, Ontario, M4N 3M5
Study site
Vancouver, British Columbia, V6Z 1Y6
About this study
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).
- Conditions
- HIV Infections, Fanconi Syndrome, Kidney Disease, Renal Impairment
- Being tested
- Blood Draws
- Keywords
- Fanconi, Kidney, Renal, HIV, HIV-1, Treatment Experienced
- Medical subject headings
- HIV Infections, Fanconi Syndrome, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawsProcedure or surgery
A single whole blood sample was collected for genomic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Fanconi Cases | This cohort enrolled participants with evidence of protocol-defined Fanconi syndrome (confirmed creatinine clearance decline and evidence of proximal tubulopathy). Receives: Procedure: Blood Draws | |
| Control Cases | This cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome. Receives: Procedure: Blood Draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to TDF discontinuation after diagnosis of Fanconi syndrome
Measured: Up to 48 weeks
Time to confirmed resolution of Fanconi syndrome
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Flaherty, PharmD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499187
- Sponsor's protocol ID
- GS-US-104-0353
- Status last verified
- Mar 2014
- First submitted
- 9 Jul 2007
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Evaluation of Fanconi Syndrome Due to Antiretroviral Therapies in HIV-Infected Persons
- ClinicalTrials.gov ID
- NCT00499187
- Acronym / sponsor ID
- GS-US-104-0353
- Conditions
- HIV Infections, Fanconi Syndrome, Kidney Disease, Renal Impairment
- Keywords
- Fanconi, Kidney, Renal, HIV, HIV-1, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fanconi Cases | – | Procedure: Blood DrawsThis cohort enrolled participants with evidence of protocol-defined Fanconi syndrome (confirmed creatinine clearance decline and evidence of proximal tubulopathy). |
| Control Cases | – | Procedure: Blood DrawsThis cohort enrolled participants with no evidence of protocol-defined Fanconi syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected subjects with protocol defined Fanconi Syndrome
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Subjects who meet the following exclusion criteria are not to be enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawsA single whole blood sample was collected for genomic analysis. | Procedure or surgery | Control Cases, Fanconi Cases |
Primary outcome
Time to TDF discontinuation after diagnosis of Fanconi syndrome
Time frame: Up to 48 weeks
Time to confirmed resolution of Fanconi syndrome
Time frame: Up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Flaherty, PharmD study director
Gilead Sciences
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Fanconi Syndrome, run by Gilead Sciences at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to TDF discontinuation after diagnosis of Fanconi syndrome (time frame: Up to 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.