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NCT03123575 Clinical Trial

Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy

HIV Clinical Trial

— PODIUM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03123575
Other study ID # FIBHGM-EONC002-2016
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 17, 2017
Last updated June 8, 2017
Start date June 2017
Est. completion date October 2017

Study information
Verified date June 2017
Source Hospital General Universitario Gregorio Marañon
Contact Juan Berenguer, PhD
Phone +34620038850
Email jbb4@me.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients who picked-up Co-meds in the study period

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Hospital General Universitario Gregorio Marañon Merck Sharp & Dohme Corp., Molecular-Clinical Pharmacol/Instit.Translational Medicine/University Liverpool, SERMAS

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
Primary 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 6 months
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