The impact of switching to two-drug antiretroviral therapy on body weight and metabolic profiles: A randomized, open-label, two-parallel-group, multicenter trial.
- Conditions
- Human immunodeficiency virus infection
- Registration Number
- JPRN-UMIN000048446
- Lead Sponsor
- Jichi Medical University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method