Older HIV-infected Adults and Drug Interactions: French C... | NCT03416881

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

NCT03416881

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jan 31, 2018Actual

Enrollment

13,225Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Nov 9, 2017

First Submission Date that Met QC Criteria

Jan 30, 2018

First Posted Date

Jan 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Jan 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13,225Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
costs associated with major drug-drug interactions	The costs were defined as all reimbursed healthcare acts recorded in the SNIIRAM	during 2016

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

66 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

French older HIV-infected adults (over than 65 years)

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided