Safety analysis of anti-retroviral drug: Biktarvy for Japanese elderly patients.

Not Applicable

• Conditions: HIV-1 infection

• Registration Number: JPRN-UMIN000041113
• Lead Sponsor: ational Center for Global Health and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-17
• Study Completion: 2023-05-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate effectiveness as the ratio of the patients with suppressed viral load (< 50c/mL).

Secondary Outcome Measures

Name	Time	Method
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.