NCT03416881

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
Last Updated

January 31, 2018

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 9, 2017

Last Update Submit

January 30, 2018

Conditions

HIV Infections

Keywords

HIV infectionantiretroviralaging populationdrug interactionscross-sectional studySNIIRAM

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • costs associated with major drug-drug interactions

    during 2016

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

January 31, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

January 31, 2018

Record last verified: 2017-11