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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV
• Intervention / Treatment: Drug: DTG + 3TC FDC

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital, 282 Munwha-ro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Estimated enrollment: 150-200 subjects.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DTG/3TC; Single arm cohort	Drug: DTG + 3TC FDC; None(Non-interventional, retrospective chart review, single-arm study )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving viral suppression	Virological suppression is HIV RNA viral load < 50 copies/mL	At week 48 after DTG/3TC treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CD4+cell counts	Change in CD4+ T-cell count from baseline	From baseline to week 48
Persistence on DTG/3TC	The percentage of patients remaining on DTG/3TC over time after initiating DTG/3TC.	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))	Up to 48 weeks.
Changes in BMI	Changes from baseline BMI( kg/m^2) in treatment-Naive	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.	From baseline to week 48

Collaborators and Investigators

• Sponsor: Chungnam National University Hospital
• Investigators: Study Director: Yeon-sook kim, Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CNUH 2024-10-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No