Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'

NCT04653194 | Completed Phase 3

• 2 other identifiers: CRF0022019-003208-11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. Time to cART start is currently approximately 2-4 weeks after diagnosis, mostly deferred for reasons of waiting for baseline blood test results; in particular HIV genotype, CD4 count, OI screen and logistics of a consultant clinical review. Whilst there is a clear rationale for this delay there is a risk of loss to follow-up as well as the potential risk of onward viral transmission. The balance between "readiness" to start ART against pragmatic and practical safe initiation of treatment needs to be tested using currently available safe potent antiretroviral agents in a head-to-head comparison study to allow careful rigorous comparisons of outcomes. This study will recruit 36 newly diagnosed HIV patients to be started on treatment immediately upon diagnosis. This would optimally be within 7 days, for eligibility to the study up to 14 days will be permissible. Patients will be randomised to one of two open-label combination therapies known to be highly effective; Biktarvy or Symtuza. The patients will receive study treatment for 48 weeks. The two therapies will be compared by the change in HIV viral load from start of treatment to 12 weeks. Further clinical data will be recorded for the trial patients and exploratory investigations undertaken. As those recruited to the trial may not be representative of the full cohort of newly diagnosed HIV patients there will also be data collected on all newly diagnosed patients in a given period. This data will contribute to conclusions on the benefits and issues of implementing test and treat.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Rate of HIV viral load response to first-line anti-retroviral treatment

  Change from baseline to week 12 in log10 HIV RNA level recorded in viral load assays.

  Baseline to 12 weeks

Secondary Outcomes (3)

• Absolute efficacy in achieving viral suppression of newly diagnosed HIV infection.

  2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks

• Adverse events occurrence

  Baseline to 48 weeks

• Viral resistance occurrence

  Baseline to 48 weeks

Study Arms (2)

Biktarvy treatment

EXPERIMENTAL

First-line HIV treatment of Biktarvy OD for 48 weeks

Drug: Biktarvy

Symtuza treatment

ACTIVE COMPARATOR

First-line HIV treatment of Symtuza OD for 48 weeks

Drug: Symtuza

Interventions

Biktarvy DRUG

Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg

Biktarvy treatment

Symtuza DRUG

Combination single tablet anti-retroviral therapy: darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg

Symtuza treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female aged 18 years or over.
• Confirmed diagnosis of HIV-1 as per local clinic definition less than 14 days before day treatment is to be initiated.
• Is capable of giving informed consent.
• Is willing to comply with the protocol requirements
• A female may be eligible to enter and participate in the study if she:
• is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
• is of child-bearing potential with a negative pregnancy test at Screening (\& baseline visit) and agrees to use one of the methods of contraception to avoid pregnancy indicated in Appendix 4 during the study and for a period of 12 weeks after the study.
• Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 4) must be using an adequate method of contraception as listed in Appendix 4 to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study;

You may not qualify if:

• Infected by HIV-2
• On PEP
• Use of medications that are know to interact with either treatment B or S
• Unstable health conditions that according to the opinion of the Investigator suggest the individual should not take part in the trial (including unstable liver diseases, possible opportunistic infections, etc)
• Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 4.4; Withdrawal Criteria and Section 10.4; Collection and Follow up of Adverse Events if pregnancy does occur in a trial subject)
• Known acute or chronic viral hepatitis including, but not limited to, A, B, or C
• Any investigational drug within 30 days prior to the trial drug administration
• Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• Imperial College London: collaborator
• Gilead Sciences: collaborator

Study Sites (3)

Brighton and Sussex University Hospitals NHS Trust Lawson Unit Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (1)

• Khawaja AA, Whitlock G, Fidler S, Soler-Carracedo A, Henderson M, Taylor GP, Boffito M, Emerson M. Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start. HIV Res Clin Pract. 2025 Dec;26(1):2447015. doi: 10.1080/25787489.2024.2447015. Epub 2025 Jan 7.

  PMID: 39763430 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; symtuza

Condition Hierarchy (Ancestors)

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

Study Officials

• Marta Boffito, MD PhD FRCP

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label 1:1 non-inferiority randomised clinical trial

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: September 30, 2020
• Primary Completion: July 30, 2023
• Study Completion: July 31, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)