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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004837-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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 ClÃnic 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy | Experimental | This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 ClÃnic HIV Unit |
| 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:
| week 4 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torres Berta, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39045754 | Derived | 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. |
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A plan description will be provided once it is decided
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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This is an open-label, single arm, single-centre prospective study
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| 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 |