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 suppressio
Phase 4
Recruiting
- Conditions
- Creatinine level and lipid profile of virally-suppressed adolescent and young adult living with HIV who use lamivudine and dolutegravir regimenHIV, pediatrics, adolescents, anti-retroviral drugs, dolutegravir, lamivudine
- Registration Number
- TCTR20240630004
- Lead Sponsor
- Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Renal function 3, 6, and 12 months after drug changing Creatinine level
- Secondary Outcome Measures
Name Time Method ipid 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