Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
NCT ID: NCT01529749
Last Updated: 2019-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2012-02-29
2016-02-29
Brief Summary
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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%.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EFV/FTC/TDF
EFV/FTC/TDF
600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan
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.
FTC/TDF + MK-0518
FTC/TDF + MK-0518
FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
FTC/TDF+MK-0518+Losartan
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.
Interventions
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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.
EFV/FTC/TDF
600/200/245 mg, od, oral
FTC/TDF + MK-0518
FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Felipe Garcia
OTHER
Responsible Party
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Felipe Garcia
Dr
Locations
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Hospital Clinic
Barcelona, , Spain
Countries
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Other Identifiers
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2011-002071-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HIV-IMMUNESARTAN
Identifier Type: -
Identifier Source: org_study_id
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