Kidney Stone Risk Factors in Patients Infected With HIV

HIV Clinical Trial

— CALVIH  

Official title:

CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457494
• Other study ID #: Al424-986
• Status: Completed
• Start date: May 2015
• Est. completion date: March 2018

Study information

• Verified date: July 2022
• Source: Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

Description:

This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

Primary Objective :

• Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism

• Risk profile for stone recurrences estimated on risk indices in HIV1 patients

Secondary Objective(s)

• Identify prevalence of recurrences and describe co-morbidities associated with stone disease

• Describe urological management for renal stones in HIV patients

• Describe the causes of drug induced renal stones

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male or female HIV1 infected patients willing to participate in the study

• Having experienced a renal stone episode within the past six months or living with a renal stone

• Able to understand the protocol

• Giving oral consent

Exclusion Criteria:

• CT scan impossible

• Follow up impossible over 1 year

Related Conditions & MeSH terms

• HIV
• Kidney Calculi
• Nephrolithiasis

Locations

Country	Name	City	State
France	Corinne Isnard Bagnis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Corinne Isnard Bagnis

Country where clinical trial is conducted

France, 

References & Publications (4)

Abgrall S, Rachas A, Tourret J, Isnard-Bagnis C, Billaud E, Tattevin P, Costagliola D, Guiguet M, Durieux P; French Hospital Database on HIV. A multifaceted intervention designed to improve medical management of moderate to advanced chronic kidney disease — View Citation

Bigé N, Lanternier F, Viard JP, Kamgang P, Daugas E, Elie C, Jidar K, Walker-Combrouze F, Peraldi MN, Isnard-Bagnis C, Servais A, Lortholary O, Noël LH, Bollée G. Presentation of HIV-associated nephropathy and outcome in HAART-treated patients. Nephrol Di — View Citation

Tourret J, Deray G, Isnard-Bagnis C. Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? J Am Soc Nephrol. 2013 Oct;24(10):1519-27. doi: 10.1681/ASN.2012080857. Epub 2013 Sep 19. Review. — View Citation

Tourret J, Tostivint I, Deray G, Isnard-Bagnis C. [Kidney diseases in HIV-infected patients]. Nephrol Ther. 2009 Nov;5(6):576-91. doi: 10.1016/j.nephro.2009.02.007. Epub 2009 Apr 16. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative assessment of the cause of the renal stone	Qualitative assessment of the cause of the renal stone based on different biological and clinical parameters (biochemical analysis of urines, cristalluria, low dose renal CT, patient history, family history…)	at 6 months
Primary	Risk profile for recurrence of renal stone	Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure	at 12 months
Secondary	Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease		up to 12 months
Secondary	Urological management for renal stones in HIV patients		up to 12 months
Secondary	Causes of drug induced renal stones		up to 12 months
Secondary	Number of stone recurrences		at 6 months
Secondary	Number of stone recurrences		at 12 months