Same-day Antiretroviral Therapy With BIC/F/TAF

NCT04712058 | Unknown

• 1 other identifier: 202003020MIPB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

same-day initiation, rapid initiation

Outcome Measures

Primary Outcomes (2)

• Retention in care at Week 48

  The proportion of patients who returned for the scheduled clinic visit at week 48

  week 48 ± 4wk

• Viral suppression at Week 48

  The proportion of viral suppression (\<50 copies/ml) at week 48

  week 48 ± 4wk

Secondary Outcomes (4)

• Acceptability of same-day initiation

  Day 1

• Viral suppression at Week 1, 4, 48

  Week 1 ± 3 days, Week 4± 1 week, Week 48± 4 week

• Adverse effect at Week 4 and 48

  Week 4± 1 week, Week 48± 4 week

• Patient's satisfaction at Weeks 1, 4, and 48

  Week 1 ± 3 days, Week 4± 1 week, Week 48± 4 week

Study Arms (1)

Same-day initiation with BIC/F/TAF

EXPERIMENTAL

Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]

Interventions

Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy] DRUG

Biktarvy will be administered on the same day of diagnosis. The daily dosing will be continued for 48 weeks.

Same-day initiation with BIC/F/TAF

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Far Eastern Memorial Hospital: collaborator
• Mackay Memorial Hospital: collaborator
• Changhua Christian Hospital: collaborator
• Chung Shan Medical University: collaborator
• National Cheng-Kung University Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Kaohsiung Municipal Ta-Tung Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

HIV Infections

Interventions

bictegravir; Emtricitabine; tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: January 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: January 19, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)