HIV
Conditions
Interventions
Trade Name: Biktarvy
Product Name: Biktarvy
Pharmaceutical Form: Tablet
INN or Proposed INN: Bictegravir
Other descriptive name: BICTEGRAVIR SODIUM
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Seimc-Gesida Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understanding the study information provided and being capable of giving written informed consent 2. Confirmed HIV infection. 3. =18 years of age on the day of screening. 4. HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 550
Exclusion criteria
Exclusion criteria: 1. Is pregnant or lactating at the screening visit or at any time during the study or is planning on becoming pregnant over the duration of the study. 2. Evidence of Hepatitis B virus infection based on at least one positive result of testing at Screening for Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (anti-HBc) 3. Previous or current therapy with dolutegravir or bictegravir. 4. History of allergy to study drugs or their components. 5. Liver disease as defined by ALT=5xULN or ALT=3xULN and Bili =1.5xULN (with >35% direct bilirubin). 6. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones); 7. Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification and/or anticipated need for Hep C treatment. 8. Kidney disease as defined by CKD-EPI <50ml/min. 9. Any recently (<=6 months) diagnosed clinical condition or recently (<=6 months) initiated concomitant therapy that may primarily affect weight or body composition. E.g., including but not limited to endocrine disorders, osteoporosis or medications to treat these clinical conditions, with the exception of controlled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of DTG/3TC for the maintenance of virological suppression in adults with HIV infection compare to BIC/FTC/TAF and to show non inferiority of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in adults with HIV at 48 weeks. The study could allow claiming for superiority.;Secondary Objective: - To evaluate the efficacy of DTG/3TC for the maintenance of virological suppression compare to BIC/FTC/TAF. - To evaluate changes in weight and BMI from baseline. - To assess absolute values and changes from baseline in CD4+ cells count and CD4:CD8 ratio - To assess changes in total and regional fat and fat-free mass. - To assess changes in subcutaneous and visceral fat. - To assess changes in lumbar and hip bone mineral density and trabecular bone score. - To assess changes in fasting glucose, insulin, HOMA-IR, HbA1c, plasma lipids, and FIB- 4 score. - To assess changes in estimated glomerular filtration rate (CKD-EPI) and urinary protein/creatinine with both therapies at week 48 and 96. - To assess changes in blood pressure at 48 and 96 weeks. - To evaluate changes in sleep quality, anxiety and depression and quality of life at each visit. - To evaluate tolerability of DTG/3TC and BIC/FTC/TAF. - To assess genotypic resistance mutations, in case of viral failure.;Primary end point(s): Proportion of patients with plasma HIV-1 RNA =50 copies/mL (FDA Snapshot, 4% noninferiority margin) at 48 weeks.;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients with plasma HIV-1 RNA =50 copies/mL (FDA Snapshot, 4% noninferiority margin) at 96 weeks. - Proportion of patients with plasma HIV-1 RNA 5% from baseline at 48 and 96 weeks. - Absolute values and changes from baseline in CD4+ cells count and CD4:CD8 ratio at 48 and 96 weeks. - Change in total and regional (trunk and extremities) fat by DXA at 48 and 96 weeks. - Change in total and regional (trunk and extremities) fat-free mass by DXA at 48 and 96 weeks. - Change in lumbar and hip bone mineral density (BMD) and trabecular bone score (TBS) by DXA at 48 and 96 weeks. - Change in subcutaneous and visceral fat (CT) at 48 and 96 weeks. Single-slice L2-L3 abdominal CT scan when breath hold. - Change in fasting glucose, insulin, HOMA-IR, HbA1c, plasma lipids (total, HDL, and LDL cholesterol, triglycerides), and FIB-4 score at 48 and 96 weeks. - Changes in estimated glomerular filtration rate (CKD-EPI) and urinary protein/creatinine - Change in blood pressure at 48 and 96 weeks. - Change in sleep quality (Pittsburg Sleep Quality Index) , anxiety and depression (HAD), and quality of life (HIV Symptom Index questionnaire / Symptom Distress Module (HIV-SI/SDM)) at each visit. - Incidence and severity of adverse events (clinical and laboratory) and incidence of adverse events leading to treatment discontinuation. - Incidence of genotypic resistance mutations in participants with virological failure at weeks 48 and 96.;Timepoint(s) of evaluation of this end point: - Week 48 -Week 96 | — |
Countries
Spain
Contacts
Public ContactSeimc-Gesida Foundation
Seimc-Gesida Foundation
Outcome results
None listed