HIVPhase 4HIVOLNCT02522338

Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

A Phase 4 study testing iohexol in people with HIV, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR. Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV
What is being tested?: iohexol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteFrance
Study dates: Feb 2011to Dec 2013
Phase: Phase 4
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

Who may be able to join

Patients infected with HIV, and included in the cohort NADIS

Who cannot join

Patient with a known allergy
Patients treated with metformin
Patients with severe hepatic impairment defined as a TP spontaneously below 50%
Patients with a history of dysthyroidism
Patient with active neoplasia other than skin cancer
Degradation recent (not older than 3 months) in renal function defined as the deterioration of GFR over 25%.

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Estimated GFR less than 15 mL/min/1, 73m2
Pregnant or lactating
Subjects under the protection of justice

Trial locations and contacts

1 site in 1 country.

France1 site

CHU de SAINT-ETIENNE
Saint-Etienne, 42000

Other trials in France

About this study

Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR.

Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.

Conditions: HIV
Being tested: iohexol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iohexolDrug
10 ml de l'iohexol (300 mgI/ml)

Study groups in NCT02522338
Study group	Role	What they receive
iohexol plasma clearance	Other	patients had received iohexol for measuring GFR Receives: Drug: iohexol

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient with a predictive performance range -30% to +30%
for each estimator :predictive performance calculated by [(DFG estimé* - DFG mesuré par iohexol**)/DFG mesuré par iohexol]X100
Measured: day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Dec 2013

First posted13 Aug 2015 (estimated)
Study startFeb 2011
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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: Interventional
Phase: Phase 4
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02522338
Sponsor's protocol ID: 1008078
Other IDs: 2010-022272-31
Acronym: HIVOL
Status last verified: Mar 2016
First submitted: 4 Aug 2015
Last updated: 10 Mar 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
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Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric

All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance
ClinicalTrials.gov ID: NCT02522338
Acronym / sponsor ID: HIVOL / 1008078
Conditions: HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Study start: Feb 2011
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 13 Aug 2015 (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.

Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR.

Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
iohexol plasma clearance	Other	Drug: iohexolpatients had received iohexol for measuring GFR

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients infected with HIV, and included in the cohort NADIS

Key exclusion criteria (9 listed)

Patient with a known allergy
Patients treated with metformin
Patients with severe hepatic impairment defined as a TP spontaneously below 50%
Patients with a history of dysthyroidism
Patient with active neoplasia other than skin cancer

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
iohexol10 ml de l'iohexol (300 mgI/ml)	Drug	iohexol plasma clearance

Primary outcome

Patient with a predictive performance range -30% to +30%
Time frame: day 0
for each estimator :predictive performance calculated by [(DFG estimé* - DFG mesuré par iohexol**)/DFG mesuré par iohexol]X100

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 10 Mar 2016.

Related trials for HIV

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric

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.

Frédéric LUCHT, MD PhD principal investigator

CHU de SAINT-ETIENNE

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iohexol in people with HIV, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

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 1 inclusion and 9 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Patient with a predictive performance range -30% to +30% (time frame: day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02522338.

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 10 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.