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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT02522338
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Drug: iohexol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: iohexol plasma clearance patients had received iohexol for measuring GFR	Drug: iohexol; 10 ml de l'iohexol (300 mgI/ml)

Outcome Measures

Primary Outcome Measures

1. Patient with a predictive performance range -30% to +30% [day 0]

   for each estimator :predictive performance calculated by [(DFG estimé* - DFG mesuré par iohexol**)/DFG mesuré par iohexol]X100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients infected with HIV, and included in the cohort NADIS

Exclusion Criteria:

• 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%.

• Estimated GFR less than 15 mL/min/1, 73m2

• Pregnant or lactating

• Subjects under the protection of justice

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de SAINT-ETIENNE	Saint-etienne		France	42000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Frédéric LUCHT, MD PhD, CHU de SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02522338
• Other Study ID Numbers: 1008078; 2010-022272-31
• First Posted: Aug 13, 2015
• Last Update Posted: Mar 10, 2016
• Last Verified: Mar 1, 2016

Study Results

No Results Posted as of Mar 10, 2016