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

• Conditions: HIV
• Interventions: Drug: DTG + 3TC FDC

• Registration Number: NCT06928090
• Lead Sponsor: Chungnam National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-24
• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-12-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DTG/3TC	DTG + 3TC FDC	Single arm cohort

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving viral suppression	At week 48 after DTG/3TC treatment	Virological suppression is HIV RNA viral load \< 50 copies/mL

Secondary Outcome Measures

Name	Time	Method
Change in CD4+cell counts	From baseline to week 48	Change in CD4+ T-cell count from baseline
Persistence on DTG/3TC	At 48 weeks	The percentage of patients remaining on DTG/3TC over time after initiating DTG/3TC.
Reasons for Discontinuation	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))
Changes in BMI	From baseline to week 48	Changes from baseline BMI( kg/m\^2) in treatment-Naive
Changes of lipid profile	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.

Trial Locations

Locations (1)

Chungnam National University Hospital, 282 Munwha-ro; 🇰🇷 Daejeon, Korea, Republic of