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Comparison of adverse events between three-drug regimen (Tenofovir disoproxil fumarate/Lamivudine/Dolutegravir) and two-drug regimen (Lamivudine/Dolutegravir) among adolescents living with HIV with virological suppression

Comparison of adverse events between three-drug regimen (Tenofovir disoproxil fumarate/Lamivudine/Dolutegravir) and two-drug regimen (Lamivudine/Dolutegravir) among adolescents living with HIV with virological suppression

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240630004
Enrollment
48
Registered
2024-06-30
Start date
2024-05-24
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Creatinine level and lipid profile of virally-suppressed adolescent and young adult living with HIV who use lamivudine and dolutegravir regimen HIV, pediatrics, adolescents, anti-retroviral drugs, dolutegravir, lamivudine

Interventions

Participant HIV regimen will be changed to Lamivudine plus Dolutegravir regimen 1 tablet of 300 mg lamivudine and 1 tablet of 50 mg dolutegravir once a day, at least 1 year from the study initiation
Experimental Drug
Lamivudine plus Dolutegravir

Sponsors

Faculty of Medicine, Chulalongkorn University
Lead Sponsor
Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
13 Years to 24 Years

Inclusion criteria

Inclusion criteria: 1. Age 13-24 year old 2. Tenofovir disoproxil+lamivudine +dolutegravir user 2. Bodyweight more than or equal to 35 Kg 3. HIV viral load less than 50 copies/mL within 6 months 4. CD4 more than 200 cells/mm3 within 6 months 5. Known their HIV status

Exclusion criteria

Exclusion criteria: 1. Chronic HBV infection 2.Creatinine clearance less than 30 mL/min/1.73 m2 3. Hepatic impairment (Child-Pugh C)4. History of dolutegravir resistant

Design outcomes

Primary

MeasureTime frame
Renal function 3, 6, and 12 months after drug changing Creatinine level

Secondary

MeasureTime frame
Lipid status 3, 6, and 12 months after drug changing Total cholesterol, triglyceride, LDL and HDL level,Viral suppression 12 months after drug changing HIV viral load,User viewpoints throughout 2 drugs regimen 6 months after drug changing Patient reported viewpoints using a questionnaire

Countries

Thailand

Contacts

Public ContactNapat Soonthornchat

Faculty of Medicine, Chulalongkorn University

napat.s@chula.ac.th0891272325

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026