HIV InfectionsTOBITNCT06107140
Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort
An observational study of HIV Infections, run by Tourcoing Hospital at 1 site in France.
Trial summary
HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- dual therapy
- How many people
- 580 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2011to 1 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed up in a referral center for the management of PLHIV who started dual antiretroviral therapy in the period from 2011 to 2023 and whose viral load was < 50 copies/ml before initiation of dual therapy.
Who may be able to join
- hiv patient
- viral load < 50copies/ml
- patient treated with dual therapy
- patients with hospital follow-up between 2011 and 2023
Who cannot join
- adults under legal protection
- underage
Trial locations and contacts
1 site in 1 country.
About this study
HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). However, in the real world, less regular adherence to treatment, more heavily pre-treated patients and resistance to treatment make these dual therapies prescribed beyond the strict framework of clinical trials. This can lead to undesirable side effects. From the perspective of personalized medicine, it seems to be important to determine which patients are receiving dual ARV therapy, and which patients remain on it for a long time. Identifying prognostic factors would enable us to adapt therapeutic management.
- Conditions
- HIV Infections
- Being tested
- dual therapy
- Keywords
- epidemiology
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual therapyOther
The evaluation will focus on the retention of patients living with hiv on dual antiretroviral therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic switch
Proportion of patients switching from dual to triple therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2011
- Primary completion1 May 2023
- Study completion1 May 2023
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107140
- Sponsor's protocol ID
- CHT/URC/2023/13
- Acronym
- TOBIT
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort
- ClinicalTrials.gov ID
- NCT06107140
- Acronym / sponsor ID
- TOBIT / CHT/URC/2023/13
- Conditions
- HIV Infections
- Keywords
- epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 30 Oct 2023 (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.
HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). However, in the real world, less regular adherence to treatment, more heavily pre-treated patients and resistance to treatment make these dual therapies prescribed beyond the strict framework of clinical trials. This can lead to undesirable side effects. From the perspective of personalized medicine, it seems to be important to determine which patients are receiving dual ARV therapy, and which patients remain on it for a long time. Identifying prognostic factors would enable us to adapt therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed up in a referral center for the management of PLHIV who started dual antiretroviral therapy in the period from 2011 to 2023 and whose viral load was < 50 copies/ml before initiation of dual therapy.
Key inclusion criteria (4 listed)
- hiv patient
- viral load < 50copies/ml
- patient treated with dual therapy
- patients with hospital follow-up between 2011 and 2023
Key exclusion criteria (2 listed)
- adults under legal protection
- underage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual therapyThe evaluation will focus on the retention of patients living with hiv on dual antiretroviral therapy. | Other | – |
Primary outcome
therapeutic switch
Time frame: 5 years
Proportion of patients switching from dual to triple therapy
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 1 Nov 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Tourcoing Hospital at 1 site in France.
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 4 inclusion and 2 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
therapeutic switch (time frame: 5 years). 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 1 Nov 2023.