HIV-1 infection
Conditions
Interventions
This study is a single-center prospective one-arm study. This study will enroll 100 HIV-1 infected treatment-experienced patients with suppressed viral load. Antiretroviral therapy of the patients wil
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Japanese male with HIV-1infection with age of 50 years or older (2)With more than 30 ml/min creatinine clearance. BMI (weight (kg) /height (m)2) 18 to <35 (3)No known INSTI resistance (4)No prior virologic failure on INSTI (5)Be able to take medication in the morning (6)Provide written informed consent to the study
Exclusion criteria
Exclusion criteria: (1)Liver cirrhosis (2)Concurrent medication which might interact with BIC, such as metformin (3)Patients whose physicians consider the study enrollment inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate effectiveness as the ratio of the patients with suppressed viral load (< 50c/mL). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint includes virologic failure as viral load of >200 copies /mL at weeks 24 and 48 and emergence of drug resistance, safety and tolerability over 48 weeks, and drug concentrations (peak and trough) at over 4 weeks of the treatment. For subgroup of 10 patients who undergo intensive 24-hr PK monitoring, PK parameters such as AUC, Cmax, Tmax will be calculated. | — |
Countries
Japan
Contacts
Public ContactKoji Watanabe
National Center for Global Health and Medicine AIDS Clinical Center
Outcome results
None listed