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Enrolling by Invitation

NCT Number: NCT06928090

Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients

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.

Enrolling by Invitation

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Key information

Conditions

HIV

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospital, 282 Munwha-ro

Daejeon, 35015, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 diagnosis
  • Prescribed DTG/3TC alone to manage HIV-1 infection as initial antiretroviral treatment at the study centers

Exclusion criteria

  • HIV-2 diagnosis
  • Previous antiretroviral treatment

Treatment and study plan

DTG + 3TC FDC

Drug

None(Non-interventional, retrospective chart review, single-arm study )

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in CD4+cell counts

    Time frame: From baseline to week 48

    Change in CD4+ T-cell count from baseline

  2. Persistence on DTG/3TC

    Time frame: At 48 weeks

    The percentage of patients remaining on DTG/3TC over time after initiating DTG/3TC.

  3. Reasons for Discontinuation

    Time frame: Up to 48 weeks.

    Reason for discontinuation (HBV co-infection, Virological Failure, Blip, Simplification, Drug-drug Interactions, AE/SAE, Pregnancy, Cost, Patient Preference, Follow-up loss))

  4. Changes in BMI

    Time frame: From baseline to week 48

    Changes from baseline BMI( kg/m^2) in treatment-Naive

  5. Changes of lipid profile

    Time frame: From baseline to week 48

    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.

Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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