Title
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
Phase
Phase 4Lead Sponsor
Hospital Clinic of BarcelonaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HIV-1 InfectionIntervention/Treatment
efavirenz tenofovir emtricitabine losartan raltegravir ...Study Participants
48This 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%.
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.
Inclusion Criteria: Patients older than 18 years. Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL <37 copies) for at least 48 weeks. Nadir CD4 +> 250 cells/mm3. Patients, properly informed, give their written consent to participate in the study. Exclusion Criteria: Criteria for patients with AIDS. Patients with active opportunistic diseases. Patients coinfected with HCV. Patients without tonsillar tissue. Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II. Kidney failure.(Glomerular Filtration Rate (GFR < 60 mL/mn) Severe liver failure (PT> 60% ). Pregnant women Known hypersensitivity or contraindication to any study drug. determination of blood pressure (BP) <100/60 mmHg Hyponatremia with serum Na numbers <132 Meq / l History of chronic vomiting the last 6 months History of chronic diarrhea the last 6 months
| Event Type | Organ System | Event Term | EFV/FTC/TDF | EFV/FTC/TDF + Losartan | FTC/TDF + MK-0518 | FTC/TDF+MK-0518+Losartan |
|---|
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)
