HIV infection MedDRA version: 20.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Product Name: bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafen
Product Code: J05AR20
Pha
Sponsors
Institut d’Investigacions Biomèdiques August Pi i Sunyer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stable and asymptomatic HIV-infected adults (=18 years) on BETAF once daily for at least the previous 6 months. 2) Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months 3) CD4 cell counts greater than 350 cells/mL at the time of consideration for the study 4) 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 5) Patients agreed to participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1) Prior virological failure to any antiretroviral regimen or documented resistance mutations to bictegravir, emtricitabine, or tenofovir 2) Any diagnosis of psychiatric illness 3) Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment) 4) Patients co-infected with HIV and active hepatitis B or C virus 5) Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1- Viral efficacy (standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL) of the reduction of BETAF regimen dose per week at 4 weeks. 2- Viral efficacy (standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL) of the reduction of BETAF regimen dose per week at 48 weeks.;Secondary Objective: 1-Virological efficacy: at 0, 4, 12, 24, 36, and 48 weeks d. Ultrasensitive plasma viral load at 0, 4, and 48 weeks e. HIV-1 reservoir (total and integrated DNA) in CD4 cells at 0, 4, and 48 weeks. f. In case of virological failure, ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance 2- Immunological safety: a. CD4 and CD8 cells, CD4/CD8 ratio, inflammation markers at 0, 4, and 48 weeks 3- Subclinical toxicity: a. Cummulated incidental adverse events at 48 weeks b. Weight and body mass index (BMI) changes at 4, 12, 24, 36, and 48 weeks c. Body composition at 0 and 48 weeks d. sleep quality e. quality of life 4. Pharmacokinetics of antiretroviral drugs at baseline 4, and 48 weeks: a. Plasma levels of bictegravir, emtricitabine and tenofovir b. Intracellular levels of bictegravir and phosphorylated emtricitabine and tenofovir .;Primary end point(s): Primary outcomes will be defined as: Patients with VL <50 copies at 4 weeks (FDA snapshot algorithm) in the intention-to-treat (ITT) population. - Patients with VL <50 copies at 48 weeks (FDA snapshot algorithm) in the intention-to-treat (ITT) population. 1-Virological efficacy: a. Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL) at 12, 24, and 36 weeks b. Blips (VL =50 copies/mL followed by VL <50 copies/mL) at 12, 24, 36, and 48 weeks. c. Target not detected with standard plasma viral load (lower limit of detection HIV RNA 50 copies/mL) at 0, 4, 12, 24, 36, and 48 weeks d. Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) at 0, 4, and 48 weeks e. HIV- | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Virological efficacy: a. Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL) at 12, 24, and 36 weeks b. Blips (VL =50 copies/mL followed by VL <50 copies/mL) at 12, 24, 36, and 48 weeks. c. Target not detected with standard plasma viral load (lower limit of detection HIV RNA 50 copies/mL) at 0, 4, 12, 24, 36, and 48 weeks d. Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) at 0, 4, and 48 weeks e. HIV-1 reservoir (total and integrated DNA) in CD4 cells at 0, 4, and 48 weeks. f. In case of virological failure, ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance 2- Immunological safety: a. CD4 and CD8 cells, CD4/CD8 ratio at 0, 4, and 48 weeks b. Inflammation (hsCRP, IL-6, adiponectin) and immune activation (sCD14, CD163) markers at 0, 4, and 48 weeks 3- Subclinical toxicity: a. Cummulated incidental adverse events at 48 weeks b. Weight and body mass index (BMI) changes at 4, 12, 24, 36, and 48 weeks c) Body composition (fat, fat-free mass, and bone by DEXA,) at 0 and 48 weeks d. Impact on sleep quality (Pittsburg Sleep Quality Index) at 0 and 48 weeks e. Impact on quality of life (EQ-5D-5L) at 0 and 4,12,24,36, 48 weeks 4- Pharmacokinetics of antiretroviral drugs at baseline and at 4, and 48 weeks a. Plasma levels of bictegravir, emtricitabine and tenofovir b. Intracellular levels of bictegravir, phosphorylated emtricitabine and phosphorylated tenofovir .;Timepoint(s) of evaluation of this end point: The patient may also discontinue study participation in the following instances: 1. If the investigator considers in the interest of the subject (i.e intercurrent illness, occurrence of adverse events) that it is best for them to stop study medication. 2. The subject fails to comply with the protocol requirements or fails to cooperate with investigator. 3.If a female subject becomes pregnant along the | — |
Countries
Spain
Contacts
Public ContactAnna Cruceta
CTU(clinical Trial Unit)
Outcome results
None listed