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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

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ClinicalTrials.gov Identifier: NCT01529749
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE February 8, 2012
First Posted Date  ICMJE February 9, 2012
Results First Submitted Date  ICMJE April 17, 2018
Results First Posted Date  ICMJE August 2, 2019
Last Update Posted Date August 2, 2019
Study Start Date  ICMJE February 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01529749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Proportion of Patients With Changes in the Levels of IL-6 in Different Groups. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Changes in the Levels of CRP in Different Groups. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Changes in the Levels of D-dimer in Different Groups. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Increased CD4 in Peripheral Blood. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Increased CD4 in Lymphatic Tissue. [ Time Frame: week 48 ]
  • Proportion of Patients With Undetectable Plasma Viral Load in Different Groups [ Time Frame: 48 weeks ]
  • Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups [ Time Frame: week 48 ]
  • Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Changes in Levels of Metalloproteinases [ Time Frame: 48 weeks ]
  • Proportion of Patients With Changes in Levels of beta2-microglobulin. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Changes in Levels of CSF Cells. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Changes in Levels of Proteins. [ Time Frame: 48 weeks ]
  • Proportion of Patients With Improvement in Neuropsychological Test [ Time Frame: 48 weeks ]
  • Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups. [ Time Frame: up to 48 weeks ]
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • Proportion of patients with changes in the levels of IL-6, D-dimer and CRP in different groups. [ Time Frame: 12, 24, 36 and 48 weeks ]
  • Proportion of patients with increased CD4 in peripheral blood and in lymphatic tissue. [ Time Frame: peripheral blood: 12, 24, 36 and 48 weeks, Lymphatic tissue: week 48 ]
  • Proportion of patients with undetectable plasma viral load and decreased in lymphatic tissue in different groups [ Time Frame: VL in plasma: 12, 24, 36, 48 weeks, Lymphatic tissue: week 48 ]
  • Proportion of patients with changes in the CD4/CD8 ratio in peripheral blood in different groups. [ Time Frame: 12, 24, 25 and 48 weeks ]
  • Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups. [ Time Frame: 48 weeks ]
  • Proportion of patients with changes in levels of metalloproteinases and their inhibitors, beta2-microglobulin and CSF cells and proteins. [ Time Frame: 48 weeks ]
  • Proportion of patients with improvement in neuropsychological test CDS [ Time Frame: 48 weeks ]
  • Incidence and types of adverse events and laboratory abnormalities in the different groups. [ Time Frame: 12, 24, 36 and 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
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%.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: EFV/FTC/TDF + Losartan
    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.
  • Drug: EFV/FTC/TDF
    600/200/245 mg, od, oral
  • Drug: FTC/TDF + MK-0518
    FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
  • Drug: FTC/TDF+MK-0518+Losartan
    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.
Study Arms  ICMJE
  • Active Comparator: EFV/FTC/TDF
    Intervention: Drug: EFV/FTC/TDF
  • Experimental: EFV/FTC/TDF + Losartan
    Intervention: Drug: EFV/FTC/TDF + Losartan
  • Experimental: FTC/TDF + MK-0518
    Intervention: Drug: FTC/TDF + MK-0518
  • Experimental: FTC/TDF+MK-0518+Losartan
    Intervention: Drug: FTC/TDF+MK-0518+Losartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529749
Other Study ID Numbers  ICMJE HIV-IMMUNESARTAN
2011-002071-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felipe Garcia, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Felipe Garcia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP