HIV InfectionsPOPVIH65NCT03416881
Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study
An observational study of HIV Infections, run by University Hospital, Caen.
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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 13,225 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: French older HIV-infected adults (over than 65 years)
Who may be able to join
- Men and women over than 65 years with an HIV infection and insured at the French Primary Health Insurance fund
- No exclusion Criteria
Who cannot join
None listed.
About this study
Official title: Older HIV-infected Adults and Drug Interactions: Nationwide Cross-sectional Study Based on French National Health Insurance Databases
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.
Read the 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
- Conditions
- HIV Infections
- Keywords
- HIV infection, antiretroviral, aging population, drug interactions, cross-sectional study, SNIIRAM
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: between Jan, 1st 2016 and Dec, 31st 2016
Secondary outcomes (1)
costs associated with major drug-drug interactions
The costs were defined as all reimbursed healthcare acts recorded in the SNIIRAM
Measured: during 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 13,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416881
- Sponsor's protocol ID
- 1934895
- Acronym
- POPVIH65
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older HIV-infected Adults and Drug Interactions: Nationwide Cross-sectional Study Based on French National Health Insurance Databases
- ClinicalTrials.gov ID
- NCT03416881
- Acronym / sponsor ID
- POPVIH65 / 1934895
- Conditions
- HIV Infections
- Keywords
- HIV infection, antiretroviral, aging population, drug interactions, cross-sectional study, SNIIRAM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,225 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Jan 2018 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- French older HIV-infected adults (over than 65 years)
Key inclusion criteria (2 listed)
- Men and women over than 65 years with an HIV infection and insured at the French Primary Health Insurance fund
- No exclusion Criteria
Key exclusion criteria (0 listed)
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
frequency of major drug-drug interactions
Time frame: between Jan, 1st 2016 and Dec, 31st 2016
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).
1 secondary outcome
costs associated with major drug-drug interactions
Time frame: during 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University Hospital, Caen.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 31 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of major drug-drug interactions (time frame: between Jan, 1st 2016 and Dec, 31st 2016). 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 31 Jan 2018.