Phase 4 Completed N=48 Randomized Treatment

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

Source: ClinicalTrials.gov NCT01529749 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcomePrimary: Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue. — 0; 0; 0; 0 participants — p=1

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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%.

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in the Levels of CRP in Different Groups.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Increased CD4 in Peripheral Blood.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Increased CD4 in Lymphatic Tissue.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Undetectable Plasma Viral Load in Different Groups	12; 10; 10; 10	1
SECONDARY Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups	12; 10; 10; 10	1
SECONDARY Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.	-0.03; 0.04; 0.36; 0.37	0.01 sig
SECONDARY Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in Levels of Metalloproteinases	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in Levels of beta2-microglobulin.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in Levels of CSF Cells.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Changes in Levels of Proteins.	0; 0; 0; 0	1
SECONDARY Proportion of Patients With Improvement in Neuropsychological Test	0; 0; 0; 0	1
SECONDARY Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.	6; 6; 3; 6	0.49
SECONDARY Changes in CD4 CD38+ HLADR+ (%)	2.3; 4; 1.8; 2.2	0.02 sig

Eligibility Criteria

Inclusion Criteria

Patients older than 18 years.
Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL 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% ).
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01529749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.