NCT06928090

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 24, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Expected
Last Updated

April 15, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 27, 2025

Last Update Submit

April 7, 2025

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients achieving viral suppression

    Virological suppression is HIV RNA viral load \< 50 copies/mL

    At week 48 after DTG/3TC treatment

Secondary Outcomes (5)

  • Change in CD4+cell counts

    From baseline to week 48

  • Persistence on DTG/3TC

    At 48 weeks

  • Reasons for Discontinuation

    Up to 48 weeks.

  • Changes in BMI

    From baseline to week 48

  • Changes of lipid profile

    From baseline to week 48

Study Arms (1)

DTG/3TC

Single arm cohort

Drug: DTG + 3TC FDC

Interventions

DTG + 3TC FDCDRUG

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

DTG/3TC

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Estimated enrollment: 150-200 subjects.

You may qualify if:

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

You may not qualify if:

  • HIV-2 diagnosis
  • Previous antiretroviral treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital, 282 Munwha-ro

Daejeon, 35015, South Korea

Location

MeSH Terms

Interventions

dolutegravir

Study Officials

  • Yeon-sook kim

    Chungnam National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 15, 2025

Study Start

January 24, 2025

Primary Completion

December 30, 2025

Study Completion (Estimated)

January 30, 2027

Last Updated

April 15, 2025

Record last verified: 2025-03

Locations

KR(1)