Clinical trial 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
Official title: Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1 Infection
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
timeFrame: 48 weeks
measure: Proportion of Patients With Changes in the Levels of CRP in Different Groups.
timeFrame: 48 weeks
measure: Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
timeFrame: 48 weeks
measure: Proportion of Patients With Increased CD4 in Peripheral Blood.
timeFrame: 48 weeks
measure: Proportion of Patients With Increased CD4 in Lymphatic Tissue.
timeFrame: week 48
measure: Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
timeFrame: 48 weeks
measure: Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
timeFrame: week 48
measure: Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
timeFrame: 48 weeks
measure: Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
timeFrame: 48 weeks
measure: Proportion of Patients With Changes in Levels of Metalloproteinases
timeFrame: 48 weeks
measure: Proportion of Patients With Changes in Levels of beta2-microglobulin.
timeFrame: 48 weeks
measure: Proportion of Patients With Changes in Levels of CSF Cells.
timeFrame: 48 weeks
measure: Proportion of Patients With Changes in Levels of Proteins.
timeFrame: 48 weeks
measure: Proportion of Patients With Improvement in Neuropsychological Test
timeFrame: 48 weeks
measure: Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
timeFrame: up to 48 weeks
measure: Changes in CD4 CD38+ HLADR+ (%)
timeFrame: 0, 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: