This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels. Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be \<4.5 or ≥ 4.5).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
oral, 800/100 mg, qd + oral, 300/200 mg, qd
oral, 300/100 mg, qd + oral, 300/200 mg, qd
Hospital Clinic
Barcelona, Barcelona, Spain
Changes in total cholesterol
Time frame: 24 weeks
Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol
Time frame: 24, 48 and 96 weeks
Cardiovascular risk according to the Framingham scale.
Time frame: 24, 48 and 96 weeks.
Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index))
Time frame: 24, 48 and 96 weeks
inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin)
Time frame: 24, 48 and 96 weeks
RNA viral load <50 copies / mL
Time frame: 24, 48 and 96 weeks.
CD4+ cells count
Time frame: 24, 48 and 96 weeks
clinical adverse events, including events related to depositional patterns, laboratory abnormalities and incidence of treatment discontinuation because of toxicity or intolerance in each of the treatment arms.
Time frame: 24, 48 and 96 weeks
distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan
Time frame: 48 and 96 weeks
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