Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated

Felipe Garcia

Status and phase: Completed; Phase 4

Conditions: HIV-1 Infection

Treatments: Drug: EFV/FTC/TDF; Drug: FTC/TDF + MK-0518; Drug: EFV/FTC/TDF + Losartan; Drug: FTC/TDF+MK-0518+Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01529749

2011-002071-42 (EudraCT Number)

HIV-IMMUNESARTAN

Details and patient eligibility

About

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%.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

EFV/FTC/TDF

Active Comparator group

Treatment:

Drug: EFV/FTC/TDF

EFV/FTC/TDF + Losartan

Experimental group

Treatment:

Drug: EFV/FTC/TDF + Losartan

FTC/TDF + MK-0518

Experimental group

Treatment:

Drug: FTC/TDF + MK-0518

FTC/TDF+MK-0518+Losartan

Experimental group

Treatment:

Drug: FTC/TDF+MK-0518+Losartan