Renal ToxicityComorVIHNCT02116751
Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients
An observational study of Renal Toxicity, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
Trial summary
The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Toxicity
- How many people
- 306 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients in active follow up, receiving antiretroviral therapy
Who may be able to join
- Confirmed HIV infection
Who cannot join
- Pregnancy
- Prior therapy with antineoplastic chemotherapy or chronic treatment with corticosteroids
- Previous chronic therapy with antiresorptive bone therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy
The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the effects of antiretroviral medication.
Read the detailed description
This is a retrospective cohort study involving 300 patients to determine the frequency of renal and bone comorbidities/toxicity in a large population of HIV-infected patients receiving antiretroviral therapy, in order to establish the differential role of classical factors, HIV infection, or antiretroviral therapy.
- Conditions
- Renal Toxicity
- Keywords
- HIV, antiretroviral, toxicity, eGFR, tubular disease, BMD
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Renal and Bone toxicity
Number and percentage of patients with:
- Confirmed estimated glomerular filtration rate (eGFR) by CKD (chronic kidney disease)-epi equation decrease to < 60 ml/min, or/and
- More than 25% of eGFR decrease during therapy, or/and
- Tubular toxicity defined as at least two of confirmed proteinuria (> 300 mg/g), glycosuria with euglycemia, fractional excretion of urinary phosphate > 20%, or of uric acid > 10%. AND
- Number and percentage of patients with bone mineral density (BMD) decrease > 10% during follow up or progression to osteopenia (from normal) or to osteoporosis (from osteopenia)
Measured: Patients will be evaluated for 2 years before
Secondary outcomes (1)
Consequences of renal or bone toxicity
Percentage of patients with regimen discontinuation (any drug in the regimen) because of renal or/and bone toxicity
Measured: Patients will be evaluated for 2 years before
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jose L Casado, MD, Principal investigator, Ramon y Cajal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116751
- Sponsor's protocol ID
- EC 039/14
- Acronym
- ComorVIH
- Status last verified
- Apr 2014
- First submitted
- 11 Apr 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02116751
- Acronym / sponsor ID
- ComorVIH / EC 039/14
- Conditions
- Renal Toxicity
- Keywords
- HIV, antiretroviral, toxicity, eGFR, tubular disease, BMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades InfecciosasResearch network
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the effects of antiretroviral medication.
Detailed description
This is a retrospective cohort study involving 300 patients to determine the frequency of renal and bone comorbidities/toxicity in a large population of HIV-infected patients receiving antiretroviral therapy, in order to establish the differential role of classical factors, HIV infection, or antiretroviral therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients in active follow up, receiving antiretroviral therapy
Key inclusion criteria (1 listed)
- Confirmed HIV infection
Key exclusion criteria (3 listed)
- Pregnancy
- Prior therapy with antineoplastic chemotherapy or chronic treatment with corticosteroids
- Previous chronic therapy with antiresorptive bone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Renal and Bone toxicity
Time frame: Patients will be evaluated for 2 years before
Number and percentage of patients with: * Confirmed estimated glomerular filtration rate (eGFR) by CKD (chronic kidney disease)-epi equation decrease to < 60 ml/min, or/and * More than 25% of eGFR decrease during therapy, or/and * Tubular toxicity defined as at least two of confirmed proteinuria (> 300 mg/g), glycosuria with euglycemia, fractional excretion of urinary phosphate > 20%, or of uric acid > 10%. AND * Number and percentage of patients with bone mineral density (BMD) decrease > 10% during follow up or progression to osteopenia (from normal) or to osteoporosis (from osteopenia)
1 secondary outcome
Consequences of renal or bone toxicity
Time frame: Patients will be evaluated for 2 years before
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Casado, MD principal investigator
Ramon y Cajal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Toxicity, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Renal and Bone toxicity (time frame: Patients will be evaluated for 2 years before). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.