Kidney Stone Risk Factors in Patients Infected With HIV

Completed

• Conditions: Nephrolithiasis; HIV

• Registration Number: NCT02457494
• Lead Sponsor: Corinne Isnard Bagnis

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

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Primary Completion: 2017-10
• Study Completion: 2018-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative assessment of the cause of the renal stone	at 6 months	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...)
Risk profile for recurrence of renal stone	at 12 months	Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure

Secondary Outcome Measures

Name	Time	Method
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
Causes of drug induced renal stones	up to 12 months
Number of stone recurrences	at 12 months
Urological management for renal stones in HIV patients	up to 12 months

Trial Locations

Locations (1)

Corinne Isnard Bagnis; 🇫🇷 Paris, France