Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
Condition: HIV-1 Infection
MeSH terms: Inflammation
Intervention: EFV/FTC/TDF + Losartan; EFV/FTC/TDF; FTC/TDF + MK-0518; FTC/TDF+MK-0518+Losartan
Intervention description: 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.
Intervention MeSH terms: Raltegravir Potassium; Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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%.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients older than 18 years.

          2. Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with
             undetectable viral load (VL <37 copies) for at least 48 weeks.

          3. Nadir CD4 +> 250 cells/mm3.

          4. Patients, properly informed, give their written consent to participate in the study.

        Exclusion Criteria:

          1. Criteria for patients with AIDS.

          2. Patients with active opportunistic diseases.

          3. Patients coinfected with HCV.

          4. Patients without tonsillar tissue.

          5. Treatment with other drugs receptor antagonists or angiotensin II converting enzyme
             inhibitors, angiotensin II.

          6. Kidney failure.(Glomerular Filtration Rate (GFR < 60 mL/mn)

          7. Severe liver failure (PT> 60% ).

          8. Pregnant women

          9. Known hypersensitivity or contraindication to any study drug.

         10. determination of blood pressure (BP) <100/60 mmHg

         11. Hyponatremia with serum Na numbers <132 Meq / l

         12. History of chronic vomiting the last 6 months

         13. History of chronic diarrhea the last 6 months