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

NCT01529749 | Completed Phase 4 Results

• 2 other identifiers: HIV-IMMUNESARTAN2011-002071-42
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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%.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.

  48 weeks

Secondary Outcomes (16)

• Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.

  48 weeks

• Proportion of Patients With Changes in the Levels of CRP in Different Groups.

  48 weeks

• Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.

  48 weeks

• Proportion of Patients With Increased CD4 in Peripheral Blood.

  48 weeks

• Proportion of Patients With Increased CD4 in Lymphatic Tissue.

  week 48

Study Arms (4)

EFV/FTC/TDF

ACTIVE COMPARATOR

Drug: EFV/FTC/TDF

EFV/FTC/TDF + Losartan

EXPERIMENTAL

Drug: EFV/FTC/TDF + Losartan

FTC/TDF + MK-0518

EXPERIMENTAL

Drug: FTC/TDF + MK-0518

FTC/TDF+MK-0518+Losartan

EXPERIMENTAL

Drug: FTC/TDF+MK-0518+Losartan

Interventions

EFV/FTC/TDF + Losartan DRUG

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.

EFV/FTC/TDF + Losartan

EFV/FTC/TDF DRUG

600/200/245 mg, od, oral

EFV/FTC/TDF

FTC/TDF + MK-0518 DRUG

FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral

FTC/TDF + MK-0518

FTC/TDF+MK-0518+Losartan DRUG

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.

FTC/TDF+MK-0518+Losartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Felipe Garcia: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Losartan; Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Pyrrolidinones; Pyrrolidines

Results Point of Contact

• Title: FELIPE GARCIA ALCAIDE
• Organization: Hospital Clínic

FGARCIA@clinic.cat

34619175783

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 9, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: February 1, 2016
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-06

Locations

ES (1)