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 study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01529749
First received: February 8, 2012
Last updated: February 25, 2014
Last verified: February 2014

February 8, 2012
February 25, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
Proportion of patients with 50% reduction of fibrosis in lymphatic tissue. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01529749 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with changes in the CD4/CD8 ratio in peripheral blood in different groups. [ Time Frame: 12, 24, 25 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with reduced intima-media complex in carotid ultrasound in different groups. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with changes in levels of metalloproteinases and their inhibitors, beta2-microglobulin and CSF cells and proteins. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with improvement in neuropsychological test CDS [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Incidence and types of adverse events and laboratory abnormalities in the different groups. [ Time Frame: 12, 24, 36 and 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
Not Provided

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%.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Felipe Garcia, MD fgarcia@clinic.ub.es
Spain
 
NCT01529749
HIV-IMMUNESARTAN
No
Felipe Garcia, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Not Provided
Hospital Clinic of Barcelona
February 2014

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