This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows: Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12) The allocation will take place in two phases: Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan If losartan arm shows benefits we will proceed to the second phase: Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan. Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
EFV/FTC/TDF --\> oral, 600/200/245 mg, od Losartan --\> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
600/200/245 mg, od, oral
FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral Losartan --\> -\> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Hospital Clinic
Barcelona, Spain
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
Time frame: 48 weeks
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Increased CD4 in Peripheral Blood.
Time frame: 48 weeks
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
Time frame: week 48
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
Time frame: 48 weeks
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Time frame: week 48
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of Metalloproteinases
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of beta2-microglobulin.
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of CSF Cells.
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of Proteins.
Time frame: 48 weeks
Proportion of Patients With Improvement in Neuropsychological Test
Time frame: 48 weeks
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
Time frame: up to 48 weeks
Changes in CD4 CD38+ HLADR+ (%)
Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)
Time frame: 0, 48 weeks
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