HIV -1 InfectionNEW_ODOACRENCT06637813
Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir/Lamivudine
An observational study of HIV -1 Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV -1 Infection
- What is being tested?
- Blood sampling for evaluation of biomarkers
- How many people
- 1,220 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 Oct 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: HIV subjects treated with Dovato from 2015 to 2022. (retrospective cohort) or who will start treatment from clinical practice with Dovato
Who may be able to join
- signed informed consent
- patients treated with triple therapy who simplify to 3TC+DTG
- patients treatment-naive who start a dual therapy with 3TC+DTG from clinical practice
Who cannot join
- lack of willingness to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. The availability of different classes of antiretroviral drugs, such as nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.
- Conditions
- HIV -1 Infection
- Being tested
- Blood sampling for evaluation of biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for evaluation of biomarkersOther
Non-routine diagnostic test evaluations
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a database
Systematic and continuous collection of data related to clinical, laboratory and treatment characteristics of patients who simplify from triple standard ART or who continue dual therapy with 3TC+DTG, or treatment-naive patients who start the dual regimen with 3TC+DTG. The data will be useful for the evaluation of diagnostic and multiparametric algorithms.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Di Giambenedetto, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637813
- Sponsor's protocol ID
- 7059
- Acronym
- NEW_ODOACRE
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir/Lamivudine
- ClinicalTrials.gov ID
- NCT06637813
- Acronym / sponsor ID
- NEW_ODOACRE / 7059
- Conditions
- HIV -1 Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2034 (estimated)
- First posted
- 15 Oct 2024 (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.
The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. The availability of different classes of antiretroviral drugs, such as nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV subjects treated with Dovato from 2015 to 2022. (retrospective cohort) or who will start treatment from clinical practice with Dovato
Key inclusion criteria (3 listed)
- signed informed consent
- patients treated with triple therapy who simplify to 3TC+DTG
- patients treatment-naive who start a dual therapy with 3TC+DTG from clinical practice
Key exclusion criteria (1 listed)
- lack of willingness to provide informed consent
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 |
|---|---|---|
| Blood sampling for evaluation of biomarkersNon-routine diagnostic test evaluations | Other | – |
Primary outcome
Establishment of a database
Time frame: 10 years
Systematic and continuous collection of data related to clinical, laboratory and treatment characteristics of patients who simplify from triple standard ART or who continue dual therapy with 3TC+DTG, or treatment-naive patients who start the dual regimen with 3TC+DTG. The data will be useful for the evaluation of diagnostic and multiparametric algorithms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Simona Di Giambenedetto principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of HIV -1 Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SIMONA DI GIAMBENEDETTO, Dr (+390630155366, SIMONA.DIGIAMBENEDETTO@UNICATT.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a database (time frame: 10 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 15 Oct 2024.