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Enrolling by invitation NCT06928090

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

— Observational HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DTG + 3TC FDC.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug DTG + 3TC FDC
    None(Non-interventional, retrospective chart review, single-arm study )

Primary outcome measures

  • Percentage of patients achieving viral suppression [Time frame: At week 48 after DTG/3TC treatment]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Chungnam National University Hospital, 282 Munwha-ro — Daejeon

Identifiers

NCT: NCT06928090 · CNUH 2024-10-046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗