CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Corinne Isnard Bagnis
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Qualitative assessment of the cause of the renal stone
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Qualitative assessment of the cause of the renal stone
Time Frame: 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
Time Frame: at 12 months
Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure
Secondary Outcomes
- 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)
Investigators
Corinne Isnard Bagnis
University Professor and Hospital Practitioner
Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie