Inflammation Clinical Trial
Official title:
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.
Our general goal is to evaluate the potential effectiveness of losartan (100mg daily) for
reducing inflammation and improving immune recovery, given the potential for these treatment
effects to reduce risk for long-term non-AIDS-defining complications among older HIV positive
participants. Prior to conducting a clinical outcome trial, candidate treatments must be
studied among HIV positive patients given the unique pathogenesis driving inflammation and
disease risk.
The potential benefits of losartan (100mg daily) will be studied among HIV positive
individuals over age 50 years whose CD4 counts remain ≤600 cells/mm3. Participants (n=110, 55
per group) will be randomized to receive losartan or matching placebo daily. After
randomization, participants will start losartan (or placebo) at a dose of 50mg once daily,
increasing to 100mg once daily at the 2-week study visit pending results of a week 2 toxicity
lab evaluation (see 2.4 below for criteria). Following month 1, participants will return for
follow-up study visit procedures at months 3, 6, 9, and 12.
Changes from baseline in measures of inflammation, immune activation, immune recovery and
fibrosis within lymphatic tissues will be studied. The primary outcome will be the average of
IL-6 levels over 12 months, and the main secondary outcome will be change in CD4 count in
blood over 12 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
| Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
| Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
| Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
| Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
| Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
| Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
| Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
| Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
| Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
| Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
| Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
| Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
| Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A |