Kidney Stone Risk Factors in Patients Infected With HIV (CALVIH)

July 19, 2022 updated by: Corinne Isnard Bagnis

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Corinne Isnard Bagnis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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…)
at 6 months
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
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease
Time Frame: up to 12 months
up to 12 months
Urological management for renal stones in HIV patients
Time Frame: up to 12 months
up to 12 months
Causes of drug induced renal stones
Time Frame: up to 12 months
up to 12 months
Number of stone recurrences
Time Frame: at 6 months
at 6 months
Number of stone recurrences
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corinne Isnard Bagnis

Investigators

  • Principal Investigator: corinne i bagnis, Groupe Hospitalier Pitie Salpetriere et Chaire de Recherche en Education Therapeutique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al424-986

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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