Same-day Antiretroviral Therapy With BIC/F/TAF

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

WHO had recommened rapid ART initiation, defined as starting ART within 7 days or on the same day after HIV diagnosis, to improve HIV care continuum. Prior studies revealed that point-of-care diagnostic methods for the detection of HIV RNA can accelerate linkage to care and reduce anxiety. By shortening the interval between infectious disease physician referral, time-lag between screening and confirmatory tests, with the use of the newly developed point-of-care immunochromatographic confirmatory test, initiating a safe and potent antiretroviral therapy, BIC/F/TAF, on the same day of HIV confirmation will be feasible to improve linkage to care and to shorten the interval between HIV diagnosis and viral suppression.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborators: Changhua Christian Hospital; Chi Mei Medical Hospital; Chung Shan Medical University; Far Eastern Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Kaohsiung Municipal Ta-Tung Hospital; Mackay Memorial Hospital; National Cheng-Kung University Hospital
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Tenofovir

Criteria

Inclusion Criteria:

• Patients who test positive by HIV screening tests (4th generation Ag/Ab) by clinical care providers or by VCT counselors within 3 days of Visit 1.

• Aged 20 years or older

• Patient is willing to participate in this study and sign the written informed consent form

Exclusion Criteria:

• Prior HIV diagnosis

• Prior ART for HIV infection

• Chronic kidney disease, stage ≥4 (CCr <30 ml/min/1.73m2) or receiving dialysis

• Severe hepatic impairment (Child-Pugh score C) or clinical apparent hepatic impairment including jaundice or ascites

• Active or latent tuberculosis infection or clinical apparent central nervous system infection

• Pregnancy or breastfeeding

• Allergy to FTC or TDF containing medication