Human immunodeficiency virus infection
Conditions
Interventions
Randomly assigned (1:1) to switch to 2-drug regimen (3TC/DTG) or continue the current 3-drug regimen (TAF/FTC + DTG).
Randomly assigned (1:1) to switch to 2-drug regimen (3TC/DTG) or continue the cur
Sponsors
Jichi Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults with HIV (PWH) who have chosen to participate in research based on their own understanding and wishes. Participants must be able to understand protocol requirements, instructions, and restrictions. 2)PWH with hepatitis B virus (HBV) immunity through natural infection (anti-HBc positive, anti-HBs positive, and HBsAg negative). 3)PWH with HBV immunity following complete HBV vaccination (anti-HBs >10 mIU/mL, anti-HBc negative, and HBsAg negative). 4)PWH on 3-drug ART who achieved viral suppression (HIV-1 RNA <50 copies/mL) for at least 12 months prior to inclusion.
Exclusion criteria
Exclusion criteria: 1)Individuals with active opportunistic illnesses. 2)Any history of detection of major NRTI or INSTI mutations. 3)Any history of virologic failure (HIV-1 RNA >200 copies/mL) for which salvage therapy were required. 4)Individuals who had failed to HIV pre-exposure prophylaxis (PrEP). 5)Individuals with untreated syphilis (or until 7 days after completion of the treatment of syphilis). 6)PWH with creatine clearance of <30 mL/min/1.73m2, liver cirrhosis, malignancy, or use of cancer chemotherapeutic/immunosuppressive agents. 7)PWH with ALT >= 5 times the upper limit of normal (ULN), ALT >= 3 times ULN, and bilirubin >= 1.5 times ULN. 8)PWH with HBV infection (positive for HBsAg or HBV-DNA), history of nucleos(t)ide analogue therapy for HBV, or history of chronic HBV infection. 9)Individuals who receive or anticipate receiving treatment for hepatitis C during the study period. 10)Individuals who receive insulin therapy, SGLT-2 inhibitor, or GLP-1 receptor agonist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in metabolic and inflammatory profiles (cholesterol, triglyceride, glucose, HbA1c, HOMA-IR, C-reactive protein, and CD4+/CD8+ ratio) from baseline to weeks 48 and 96. 2)Change in body weight from baseline to week 96 | — |
Countries
Japan
Contacts
Public ContactKensuke Minami
Jichi Medical University Hospital Division of Infectious Diseases
Outcome results
None listed