HIV-1-infectionPhase 3Test&TreatNCT04416906
A Test and Treat Strategy in New HIV Diagnosis.
A Phase 3 study testing Biktarvy in people with HIV-1-infection, run by Judit Pich Martínez at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Biktarvy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2020to 11 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
- 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.
- Written informed consent.
Who cannot join
- Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- HIV-1-infection
- Being tested
- Biktarvy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiktarvyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Biktarvy | Experimental | This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide. Receives: Drug: Biktarvy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: week 4
Days since first HIV test was performed until Biktarvy is initiated.
Measured: week 4
Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.
Measured: week 4
Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 24 and week 48
Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.
Measured: week 24 and week 48
Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.
Measured: week 48
Proportion of patients with treatment-related adverse events during the study period.
Measured: week 48
Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.
Measured: week 48
Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.
Measured: week 48
Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Oct 2020
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an open-label, single arm, single-centre prospective study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judit Pich Martínez
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Torres Berta, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416906
- Sponsor's protocol ID
- Biktarvy Test&Treat
- Other IDs
- 2019-004837-17, 2019
- Acronym
- Test&Treat
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan description will be provided once it is decided
Publications
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.
PubMed 39045754
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.
- ClinicalTrials.gov ID
- NCT04416906
- Acronym / sponsor ID
- Test&Treat / Biktarvy Test&Treat
- Conditions
- HIV-1-infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Judit Pich MartínezUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single arm, single-centre prospective study
| Arm | Type | Receives |
|---|---|---|
| Biktarvy | Experimental | Drug: BiktarvyThis is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
- 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.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiktarvyOnce 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 | Drug | Biktarvy |
Primary outcome
Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4
Time frame: 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
13 secondary outcomes
Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.
Time frame: week 4
Days since first HIV test was performed until Biktarvy is initiated.
Time frame: week 4
Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.
Time frame: week 4
Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 24 and week 48
Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.
Time frame: week 24 and week 48
Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.
Time frame: week 48
Proportion of patients with treatment-related adverse events during the study period.
Time frame: week 48
Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.
Time frame: week 48
Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.
Time frame: week 48
Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.
Time frame: week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 39045754Ugarte 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.
- Individual participant dataSharing planned: Undecided. A plan description will be provided once it is decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torres Berta, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biktarvy in people with HIV-1-infection, run by Judit Pich Martínez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.