Bone health (bone mineral density, microarchitecture and bone quality) in HIV individuals under antiretroviral treatment with tenofovir disoproxil fumarate (TDF) that change treatment to bictegravir-tenofovir alafenamide-emtricitavin (BIC)
Conditions
Interventions
Trade Name: Biktarvy
Product Name: Biktarvy
Product Code: EMEA/H/C/004449
Pharmaceutical Form: Pastille
INN or Proposed INN: BICTEGRAVIR
Current Sponsor code: BIC
Concentration unit: Bq/mg becquerel(s
Sponsors
Consorci Mar Parc de Salut de Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Treated Adult patients for HIV, virologically suppressed during a regimen containing TDF for more than 48 weeks, regardless of the BMD values 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: -Patients who have been previously exposed to any medication that may affect bone, such as systemic glucocorticoids and anti-osteoporosis medications. - Patients previously diagnosed with conditions that could affect bone: chronic kidney disease (GFR MDRD <45 ml / min / 1.73m ^ 2), chronic untreated endocrine disorders, end-stage decompensated liver disease or malabsorptive disorders; or other bone diseases such as Paget's bone disease; neoplasia or any condition that, in the opinion of the investigator, may interfere with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Compare the differences in bone tissue quality (BMSi) by microindentation between the group that changes to Biktarvy and the one that follows the pattern prior to week 24 and week 48. 2. Compare the differences between the two groups with respect to the baseline value in Week 48 in bone mineral density of the lumbar (L2 - L4) and hip. 3. Compare the differences in bone microarchitecture to week 48 between the two groups by means of the Trabecular Bone Score (TBS).;Main Objective: To study three components of bone resistance (density, microarchitecture and microindentation) in HIV patients on antiretroviral treatment who change treatment to Biktarvi against patients who continue in the same treatment.;Primary end point(s): The primary endpoint of this study is an assessment of bone quality through microindentation. A decrease of =1% at 24 weeks will be established as a criterion for worsening bone quality.;Timepoint(s) of evaluation of this end point: Initial visit: treatment change or persistence will be prescribed according to the randomization. Analytical + Densitometry + Microindentation Week 24: Analytical + Densitometry + Microindentation Week 48- Analytical + Densitometry + Microindentation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Compare the differences between the two groups with respect to the baseline value in Week 48 in bone mineral density of the lumbar (L2 - L4) and hip. - Compare between the two groups the differences in bone microarchitecture at week 48 by means of Trabecular Bone Score (TBS).;Timepoint(s) of evaluation of this end point: Initial visit: treatment change or persistence will be prescribed according to the randomization. Analytical + Densitometry + Microindentation Week 24: Analytical + Densitometry + Microindentation Week 48- Analytical + Densitometry + Microindentation | — |
Countries
Spain
Contacts
Public ContactConsorci Mar Parc de Salut de Barce
Consorci Mar Parc de Salut de Barcelona
Outcome results
None listed