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

Primary Purpose

HIV-1 Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
EFV/FTC/TDF + Losartan
EFV/FTC/TDF
FTC/TDF + MK-0518
FTC/TDF+MK-0518+Losartan
Sponsored by
Felipe Garcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

EFV/FTC/TDF

EFV/FTC/TDF + Losartan

FTC/TDF + MK-0518

FTC/TDF+MK-0518+Losartan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Proportion of Patients With Increased CD4 in Peripheral Blood.
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Proportion of Patients With Changes in Levels of Metalloproteinases
Proportion of Patients With Changes in Levels of beta2-microglobulin.
Proportion of Patients With Changes in Levels of CSF Cells.
Proportion of Patients With Changes in Levels of Proteins.
Proportion of Patients With Improvement in Neuropsychological Test
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
Changes in CD4 CD38+ HLADR+ (%)
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)

Full Information

First Posted
February 8, 2012
Last Updated
June 7, 2019
Sponsor
Felipe Garcia
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1. Study Identification

Unique Protocol Identification Number
NCT01529749
Brief 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
Official Title
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Felipe Garcia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EFV/FTC/TDF
Arm Type
Active Comparator
Arm Title
EFV/FTC/TDF + Losartan
Arm Type
Experimental
Arm Title
FTC/TDF + MK-0518
Arm Type
Experimental
Arm Title
FTC/TDF+MK-0518+Losartan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EFV/FTC/TDF + 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.
Intervention Type
Drug
Intervention Name(s)
EFV/FTC/TDF
Intervention Description
600/200/245 mg, od, oral
Intervention Type
Drug
Intervention Name(s)
FTC/TDF + MK-0518
Intervention Description
FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
Intervention Type
Drug
Intervention Name(s)
FTC/TDF+MK-0518+Losartan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Time Frame
48 weeks
Title
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
Time Frame
48 weeks
Title
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Time Frame
48 weeks
Title
Proportion of Patients With Increased CD4 in Peripheral Blood.
Time Frame
48 weeks
Title
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
Time Frame
week 48
Title
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
Time Frame
48 weeks
Title
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Time Frame
week 48
Title
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Time Frame
48 weeks
Title
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Time Frame
48 weeks
Title
Proportion of Patients With Changes in Levels of Metalloproteinases
Time Frame
48 weeks
Title
Proportion of Patients With Changes in Levels of beta2-microglobulin.
Time Frame
48 weeks
Title
Proportion of Patients With Changes in Levels of CSF Cells.
Time Frame
48 weeks
Title
Proportion of Patients With Changes in Levels of Proteins.
Time Frame
48 weeks
Title
Proportion of Patients With Improvement in Neuropsychological Test
Time Frame
48 weeks
Title
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
Time Frame
up to 48 weeks
Title
Changes in CD4 CD38+ HLADR+ (%)
Description
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)
Time Frame
0, 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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