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NCT03416881 Clinical Trial

Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study

HIV Infections Clinical Trial

— POPVIH65  

Official title:
Older HIV-infected Adults and Drug Interactions: Nationwide Cross-sectional Study Based on French National Health Insurance Databases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03416881
Other study ID # 1934895
Secondary ID
Status Completed
Phase N/A
First received November 9, 2017
Last updated January 30, 2018
Start date January 1, 2016
Est. completion date December 31, 2016

Study information
Verified date November 2017
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied HIV-population is ageing. The referential of interactions is the Liverpool base.

Description:

Filters in the French social security system database, 2016 :

- Code of Pathology "Human Immunodeficiency Virus (HIV) infection" Age ≥ 65 years

- Treatment with an antiretroviral between January 1, 2016 and December 31, 2016

Recruitment information / eligibility
Status Completed
Enrollment 13225
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 66 Years and older
Eligibility Inclusion Criteria:

- Men and women over than 65 years with an HIV infection and insured at the French Primary Health Insurance fund

No exclusion Criteria

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of major drug-drug interactions MDDI between 2 drugs (ARV/ARV or ARV/non-ARV) delivered during the same period yielding to a "Do Not Coadminister" statement, according to the University of Liverpool website (www.hiv-druginteractions.org/checker). between Jan, 1st 2016 and Dec, 31st 2016
Secondary costs associated with major drug-drug interactions The costs were defined as all reimbursed healthcare acts recorded in the SNIIRAM during 2016
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