Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.
The Primary objectives are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BETAF OD arm | Active Comparator | one tablet taken orally once daily |
|
| BETAF 3W arm | Experimental | one tablet taken orally 3 days per week : Mondays, Wednesdays, and Fridays |
|
| BETAF 2W arm | Experimental | one tablet taken orally 2 days per week : Mondays, and Thursdays |
|
| BETAF 1W arm | Experimental | one tablet taken orally 1 days per week : Mondays |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biktarvy 50 mg/200 mg/25 mg film-coated tablets | Drug | The duration of the study treatment will be 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks. | standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL | at 12 weeks |
| Viral efficacy of the reduction of BETAF regimen dose per week at 48 weeks. | standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL | at 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Virological efficacy assessed by Standard plasma viral load | -Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL) | at 4, 24, and 36 weeks. |
| Virological efficacy assessed by Blips (VL ≥50 copies/mL followed) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial Barcelona | Barcelona | 08036 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
-Blips (VL ≥50 copies/mL followed)
| at 0, 4, 12, 24, 36, and 48 weeks |
| Virological efficacy assessed by Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL) | -Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL) | at 0, 4, 12, 24, 36, and 48 weeks |
| Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) | -Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) | at 0, 12, and 48 weeks. |
| Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells | - HIV-1 reservoir (total and integrated DNA) in CD4 cells | at 0, 12, and 48 weeks. |
| Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance | In case of virological failure, ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance | at 0, 4, 12, 24, 36 and 48 weeks |
| Immunological safety assessed by CD4 and CD8 cells | -CD4 and CD8 (cells/mL) will be combined to report CD4/CD8 ratio. | at 0, 12 and 48 weeks |
| Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels | -Inflammation (hsCRP, IL-6, adiponectin) (µg/mL), IL-6 (pg/mL), adiponectin (µg/mL) levels | at 0, 12 and 48 weeks |
| Immunological safety assessed by sCD14 and CD163 as a Immune activation markers | - sCD14(ng/l ) and CD163 (ng/l) plasma levels | at 0, 12 and 48 weeks |
| Subclinical toxicity assessed by BMI index | - Weight and body mass index (BMI)(kg/m2) changes | at 4, 12, 24, 36, and 48 |
| Body composition assessed by DEXA scan | -Body composition (g/cm) (fat, fat-free mass, and bone by DEXA) | at 0 and 48 weeks |
| Impact on sleep quality assessed by Pittsburg Sleep Quality | - Impact on sleep quality will be evaluated througth Pittsburg Sleep Quality (visual analog score)questionaire at 0 and 48 weeks | at 0 and 48 weeks |
| Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire | - Impact on quality of life will be evaluated througth EuroQol Group EQ-5D™ (Units on a Scale) | at 0 and 4,12,24,36, 48 weeks |
| Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir | - Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L) | at 0, 12, and 48 weeks |
| Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) | Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L) | at 0, 12, and 48 weeks |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
Not provided
Not provided
Not provided