A Test and Treat Strategy in New HIV Diagnosis. (Test&Treat)

A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Biktarvy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Berta Torres, MD; Phone Number: 4645 +34932275400; Email: btorres@clinic.cat
• Study Contact Backup: Name: Josep Mallolas; Email: mallolas@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Having confirmed HIV-1 positive test.
3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
4. Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
5. Women of child-bearing potential* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
6. Written informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
2. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment > 7 days since HIV confirmation.
3. Known hypersensitivity or intolerance of any of the components of Biktarvy®.
4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
5. Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biktarvy; This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.	Drug: Biktarvy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.	week 48
Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.	week 24 and week 48
Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.	week 24 and week 48
Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.	week 48
Proportion of patients with treatment-related adverse events during the study period.	week 48
Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.	week 48
Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.	week 48
Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.	week 48

Collaborators and Investigators

• Sponsor: Judit Pich Martínez
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Torres Berta, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Biktarvy Test&Treat; 2019-004837-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A plan description will be provided once it is decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No