HIV
Conditions
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.
Interventions
DRUGDTG + 3TC FDC
None(Non-interventional, retrospective chart review, single-arm study )
Sponsors
Chungnam National University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving viral suppression | At week 48 after DTG/3TC treatment | Virological suppression is HIV RNA viral load \< 50 copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed