HIV Infections
Conditions
Brief summary
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.
Detailed description
The Primary objectives are: 1. To assess viral efficacy of the reductions of BETAF regimen dose at 12 weeks (on-treatment and intent-to-treat populations). 2. To asess viral efficacy of the reduction of BETAF regimen dose at 48 weeks (on-treatment and intent-to-treat populations).
Interventions
The duration of the study treatment will be 48 weeks.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months. * Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months. * CD4 cell counts greater than 350 cells/mL at the time of consideration for the study. * Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods. * Patients agreed to participate.
Exclusion criteria
* Prior virological failure to any antiretroviral regimen or documented. * Any diagnosis of psychiatric illness. * Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment). * Patients co-infected with HIV and active hepatitis B or C virus. * Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks. | at 12 weeks | standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL |
| Viral efficacy of the reduction of BETAF regimen dose per week at 48 weeks. | at 48 weeks. | standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Virological efficacy assessed by Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL) | at 0, 4, 12, 24, 36, and 48 weeks | -Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL) |
| Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) | at 0, 12, and 48 weeks. | -Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) |
| Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells | at 0, 12, and 48 weeks. | \- HIV-1 reservoir (total and integrated DNA) in CD4 cells |
| Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance | at 0, 4, 12, 24, 36 and 48 weeks | In case of virological failure, ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance |
| Immunological safety assessed by CD4 and CD8 cells | at 0, 12 and 48 weeks | -CD4 and CD8 (cells/mL) will be combined to report CD4/CD8 ratio. |
| Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels | at 0, 12 and 48 weeks | -Inflammation (hsCRP, IL-6, adiponectin) (µg/mL), IL-6 (pg/mL), adiponectin (µg/mL) levels |
| Virological efficacy assessed by Standard plasma viral load | at 4, 24, and 36 weeks. | -Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL) |
| Subclinical toxicity assessed by BMI index | at 4, 12, 24, 36, and 48 | \- Weight and body mass index (BMI)(kg/m2) changes |
| Body composition assessed by DEXA scan | at 0 and 48 weeks | -Body composition (g/cm) (fat, fat-free mass, and bone by DEXA) |
| Impact on sleep quality assessed by Pittsburg Sleep Quality | at 0 and 48 weeks | \- Impact on sleep quality will be evaluated througth Pittsburg Sleep Quality (visual analog score)questionaire at 0 and 48 weeks |
| Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire | at 0 and 4,12,24,36, 48 weeks | \- Impact on quality of life will be evaluated througth EuroQol Group EQ-5D™ (Units on a Scale) |
| Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir | at 0, 12, and 48 weeks | \- Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L) |
| Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) | at 0, 12, and 48 weeks | Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L) |
| Immunological safety assessed by sCD14 and CD163 as a Immune activation markers | at 0, 12 and 48 weeks | \- sCD14(ng/l ) and CD163 (ng/l) plasma levels |
| Virological efficacy assessed by Blips (VL ≥50 copies/mL followed) | at 0, 4, 12, 24, 36, and 48 weeks | -Blips (VL ≥50 copies/mL followed) |
Countries
Spain
Outcome results
None listed