HIVPODIUMNCT03123575
Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy
An observational study of HIV, run by Hospital General Universitario Gregorio Marañon.
Trial summary
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Oct 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: ART-treated patients who picked up ARVs and of all HIV-uninfected individuals who picked up Co-meds in the study period.
Who may be able to join
- patients who picked-up Co-meds in the study period
Who cannot join
- NONE
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy in The Region Of Madrid: A Population-Based, Cross-Sectional Study
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.
Read the detailed description
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.
- Conditions
- HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of Co-meds in HIV-infected individuals on ART
number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender.
Measured: 6 months
number of Co-meds between the ART-treated population and HIV-uninfected
the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.
Measured: 6 months
prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals
prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals, with description of the types of harm expected from each different potential CSDIs identified
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startJun 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, SERMAS, Molecular-Clinical Pharmacol/Instit.Translational Medicine/University Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123575
- Sponsor's protocol ID
- FIBHGM-EONC002-2016
- Acronym
- PODIUM
- Status last verified
- Jun 2017
- First submitted
- 17 Apr 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy in The Region Of Madrid: A Population-Based, Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03123575
- Acronym / sponsor ID
- PODIUM / FIBHGM-EONC002-2016
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, SERMAS, Molecular-Clinical Pharmacol/Instit.Translational Medicine/University Liverpool
- Study start
- Jun 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 21 Apr 2017 (actual)
- 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.
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.
Detailed description
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- ART-treated patients who picked up ARVs and of all HIV-uninfected individuals who picked up Co-meds in the study period.
Key inclusion criteria (1 listed)
- patients who picked-up Co-meds in the study period
Key exclusion criteria (1 listed)
- NONE
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
the number of Co-meds in HIV-infected individuals on ART
Time frame: 6 months
number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender.
number of Co-meds between the ART-treated population and HIV-uninfected
Time frame: 6 months
the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.
prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals
Time frame: 6 months
prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals, with description of the types of harm expected from each different potential CSDIs identified
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Hospital General Universitario Gregorio Marañon.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Berenguer, PhD (+34620038850, jbb4@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of Co-meds in HIV-infected individuals on ART (time frame: 6 months). The study lists 3 primary outcomes in all. 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 Jun 2017.