Multicenter, randomized, open label pilot clinical trial with two parallel arms aimed to compare the efficacy of Raltegravir (RAL) 1200mg QD vs Darunavir/Cobicistat (DRV-cb) 800-150mg QD both in combination with alafenamide/emtricitabine (TAF/FTC) in patients with Human Inmunodefficiency Virus (HIV) infection and CD4\<200 cells/microL
The trial consists of two parallel arms to study the therapeutic success of 48 weeks, tolerability, immunological recovery, persistence of treatment, safety and results reported by the subject in severely immunocompromised HIV infected patients (with an initial CD4 count \<200 cells/μl) naive to antiretroviral therapy. Included subjects will be randomized two to one (2:1) to RAL 1200mg QD plus FTC/TAF or DRV/cb (800-150mg) plus FTC/TAF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Prescription of 2x RAL 600mg (1200MG) once daily
Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily
Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC
Number of patients that will improve when having raltegravir vs darunavir
Time frame: 48 weeks
Virological failure
Number of patients in virological failure at week 48.
Time frame: 48 weeks
Compare the proportion of patients who interrupt the treatment for any reason
Number of patients that interrupt the treatment for any reason after 48 weeks.
Time frame: 48 weeks
Analyze change (percentage) in the number of CD4 lymphocytes
Percentage of change in the number of CD4 lymphocytes after 48 weeks.
Time frame: 48 weeks
Compare the proportion of patients with CD4>200 cells/μL at end of intervention
Compare the proportion of patients with CD4\>200 cells/μL at end of intervention.
Time frame: 48 weeks
Percentage change in total cholesterol (TC)
Percentage of patients with change in total cholesterol (TC),
Time frame: 48 weeks
Percentage change in LDL and HDL cholesterol
Percentage of patients with change in LDL and HDL cholesterol
Time frame: 48 weeks
Percentage change in triglycerides
Percentage of patients with change the percentage change in triglycerides after 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 48 weeks
Percentage change in TC/HDL ratio
Percentage of patients with change in TC/HDL ratio
Time frame: 48 weeks
Change in Cardiovascular Risk 10-year predictive value (REGICOR).
Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR).
Time frame: 48 weeks
Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation
Number of patiens with changes in glomerular filtration using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.
Time frame: 48 weeks