Clinical trial NCT02457494: Kidney Stone Risk Factors in Patients Infected With HIV
Official title: CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrolithiasis
HIV
Keywords: CALVIH
Renal stone
HIV1
Renal colic
Atazanavir
Crystalluria
Chronic Kidney Disease
Calcium Oxalate
Lead sponsor: Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male or female HIV1 infected patients having experienced a renal stone episode within the past six months or living with a renal stone

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative assessment of the cause of the renal stone
timeFrame: at 6 months
measure: Risk profile for recurrence of renal stone
timeFrame: at 12 months
Secondary outcomes:
measure: Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease
timeFrame: up to 12 months
measure: Urological management for renal stones in HIV patients
timeFrame: up to 12 months
measure: Causes of drug induced renal stones
timeFrame: up to 12 months
measure: Number of stone recurrences
timeFrame: at 6 months
measure: Number of stone recurrences
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Corinne Isnard Bagnis
Study officials:
affiliation: Groupe Hospitalier Pitie Salpetriere et Chaire de Recherche en Education Therapeutique
name: corinne i bagnis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 in HIV-infected patients: a cluster randomized trial. Clin Infect Dis. 2015 Aug 1;61(3):375-84. doi: 10.1093/cid/civ310. Epub 2015 Apr 22.
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.
citation: Bige 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, Noel LH, Bollee G. Presentation of HIV-associated nephropathy and outcome in HAART-treated patients. Nephrol Dial Transplant. 2012 Mar;27(3):1114-21. doi: 10.1093/ndt/gfr376. Epub 2011 Jul 10.
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.