Conditions: HIV-1 Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief summary:
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%.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: EFV/FTC/TDF + Losartan intervention 2: EFV/FTC/TDF intervention 3: FTC/TDF + MK-0518 intervention 4: FTC/TDF+MK-0518+Losartan
Intervention descriptions: intervention 1: 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. intervention 2: 600/200/245 mg, od, oral intervention 3: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral intervention 4: 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.

Protocol document: