HIVNCT06928090
Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients
An observational study of HIV, run by Chungnam National University Hospital at 1 site in South Korea.
Trial summary
Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV
- What is being tested?
- DTG + 3TC FDC
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jan 2025to 30 Jan 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Estimated enrollment: 150-200 subjects.
Who may be able to join
- HIV-1 diagnosis
- Prescribed DTG/3TC alone to manage HIV-1 infection as initial antiretroviral treatment at the study centers
Who cannot join
- HIV-2 diagnosis
- Previous antiretroviral treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chungnam National University Hospital, 282 Munwha-ro
Daejeon, 35015
About this study
Official title: A Retrospective Observational Study of Efficacy and Safety of DTG/3TC(Dolutegravir/Lamivudine) in Treatment-naïve HIV-1 Infected Patients From at Real-life Cohort in Korea
Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC.
- Conditions
- HIV
- Being tested
- DTG + 3TC FDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTG + 3TC FDCDrug
None(Non-interventional, retrospective chart review, single-arm study )
| Study group | Role | What they receive |
|---|---|---|
| DTG/3TC | Single arm cohort Receives: Drug: DTG + 3TC FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving viral suppression
Virological suppression is HIV RNA viral load < 50 copies/mL
Measured: At week 48 after DTG/3TC treatment
Secondary outcomes (5)
Change in CD4+cell counts
Change in CD4+ T-cell count from baseline
Measured: From baseline to week 48
Persistence on DTG/3TC
The percentage of patients remaining on DTG/3TC over time after initiating DTG/3TC.
Measured: At 48 weeks
Reasons for Discontinuation
Reason for discontinuation (HBV co-infection, Virological Failure, Blip, Simplification, Drug-drug Interactions, AE/SAE, Pregnancy, Cost, Patient Preference, Follow-up loss))
Measured: Up to 48 weeks.
Changes in BMI
Changes from baseline BMI( kg/m^2) in treatment-Naive
Measured: From baseline to week 48
Changes of lipid profile
Changes of lipid profile from basliene in treatment-Naive. These changes include increased levels of total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol, triglycerides.
Measured: From baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start24 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon-sook, Kim, Chungnam National University Hospital
- Investigators
- Yeon-sook kim, Study director, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928090
- Sponsor's protocol ID
- CNUH 2024-10-046
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 15 Apr 2025
- 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study of Efficacy and Safety of DTG/3TC(Dolutegravir/Lamivudine) in Treatment-naïve HIV-1 Infected Patients From at Real-life Cohort in Korea
- ClinicalTrials.gov ID
- NCT06928090
- Acronym / sponsor ID
- CNUH 2024-10-046
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 15 Apr 2025 (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.
Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTG/3TC | – | Drug: DTG + 3TC FDCSingle arm cohort |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Estimated enrollment: 150-200 subjects.
Key inclusion criteria (2 listed)
- HIV-1 diagnosis
- Prescribed DTG/3TC alone to manage HIV-1 infection as initial antiretroviral treatment at the study centers
Key exclusion criteria (2 listed)
- HIV-2 diagnosis
- Previous antiretroviral treatment
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 |
|---|---|---|
| DTG + 3TC FDCNone(Non-interventional, retrospective chart review, single-arm study ) | Drug | DTG/3TC |
Primary outcome
Percentage of patients achieving viral suppression
Time frame: At week 48 after DTG/3TC treatment
Virological suppression is HIV RNA viral load < 50 copies/mL
5 secondary outcomes
Change in CD4+cell counts
Time frame: From baseline to week 48
Persistence on DTG/3TC
Time frame: At 48 weeks
Reasons for Discontinuation
Time frame: Up to 48 weeks.
Changes in BMI
Time frame: From baseline to week 48
Changes of lipid profile
Time frame: From baseline to week 48
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 Apr 2025.
- 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.
Yeon-sook kim study director
Chungnam National University Hospital
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, run by Chungnam National University Hospital at 1 site in South Korea.
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 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: enrolling by invitation, as of the sponsor's last update on 15 Apr 2025. 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 South Korea. 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?
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?
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?
Percentage of patients achieving viral suppression (time frame: At week 48 after DTG/3TC treatment). 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 Apr 2025.