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Completed

NCT Number: NCT02457494

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.

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Key information

Conditions

Nephrolithiasis Chronic Disease Crystalluria Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications HIV Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Colic Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Corinne Isnard Bagnis

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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…)

  2. 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

  1. 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

  2. Urological management for renal stones in HIV patients

    Time frame: up to 12 months

  3. Causes of drug induced renal stones

    Time frame: up to 12 months

  4. Number of stone recurrences

    Time frame: at 6 months

  5. Number of stone recurrences

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Corinne Isnard Bagnis

Other

Registry information

Official study title

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

Acronym: CALVIH

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 29, 2015
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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