Skip to main content
OpenTrials
Completed

NCT Number: NCT01529749

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

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%.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

600/200/245 mg, od, oral

FTC/TDF + MK-0518

Drug

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

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.

Primary outcomes

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

    Time frame: 48 weeks

Secondary outcomes

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

    Time frame: 48 weeks

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

    Time frame: 48 weeks

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

    Time frame: 48 weeks

  4. Proportion of Patients With Increased CD4 in Peripheral Blood.

    Time frame: 48 weeks

  5. Proportion of Patients With Increased CD4 in Lymphatic Tissue.

    Time frame: week 48

  6. Proportion of Patients With Undetectable Plasma Viral Load in Different Groups

    Time frame: 48 weeks

  7. Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups

    Time frame: week 48

  8. Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.

    Time frame: 48 weeks

  9. Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.

    Time frame: 48 weeks

  10. Proportion of Patients With Changes in Levels of Metalloproteinases

    Time frame: 48 weeks

  11. Proportion of Patients With Changes in Levels of beta2-microglobulin.

    Time frame: 48 weeks

  12. Proportion of Patients With Changes in Levels of CSF Cells.

    Time frame: 48 weeks

  13. Proportion of Patients With Changes in Levels of Proteins.

    Time frame: 48 weeks

  14. Proportion of Patients With Improvement in Neuropsychological Test

    Time frame: 48 weeks

  15. Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.

    Time frame: up to 48 weeks

  16. Changes in CD4 CD38+ HLADR+ (%)

    Time frame: 0, 48 weeks

    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)

Sponsors and collaborators

Lead sponsor

Felipe Garcia

Other

Registry information

Official study title

Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation

Important dates

Study start
2012
Primary completion
2012
Study completion
2016
First posted
Feb 9, 2012
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.