A Test and Treat Strategy in New HIV Diagnosis.

NCT04416906 | Completed Phase 3

• 2 other identifiers: Biktarvy Test&Treat2019-004837-17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4

  Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4: * Presence of HLA-B\* 5701 or lack of HLA test * Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment * CD4 count \< 200 cells/mm3 * Viral load \> 100.000 copies/mL * Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score \> 10% at 10 years, Kidney function (eGFR \<50mL/min), * Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI) * Hepatitis B (HBV) coinfection or lack of serology

  week 4

Secondary Outcomes (13)

• Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.

  week 4

• Days since first HIV test was performed until Biktarvy is initiated.

  week 4

• Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.

  week 4

• Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.

  week 4, week 12, week 24 and week 48

• Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.

  week 24 and week 48

Study Arms (1)

Biktarvy

EXPERIMENTAL

This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.

Drug: Biktarvy

Interventions

Biktarvy DRUG

Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit

Biktarvy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• Having confirmed HIV-1 positive test.
• Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
• Written informed consent.

You may not qualify if:

• Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment \> 7 days since HIV confirmation.
• Known hypersensitivity or intolerance of any of the components of Biktarvy®.
• Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
• Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.

Sponsors & Collaborators

• Judit Pich Martínez: lead
• Gilead Sciences: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• Ugarte A, De La Mora L, De Lazzari E, Chivite I, Fernandez E, Inciarte A, Laguno M, Ambrosioni J, Solbes E, Berrocal L, Gonzalez-Cordon A, Martinez-Rebollar M, Foncillas A, Calvo J, Blanco JL, Martinez E, Mallolas J, Torres B. Rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy in HIV infection. A prospective study. J Antimicrob Chemother. 2024 Sep 3;79(9):2343-2353. doi: 10.1093/jac/dkae235.

  PMID: 39045754 DERIVED

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

• Torres Berta, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Model Details: This is an open-label, single arm, single-centre prospective study

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: October 5, 2020
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

ES (1)