Plain English Summary
Background and study aims
The human immunodeficiency virus (HIV) is a type of virus known as a retrovirus. HIV attacks and weakens the immune system, making it more difficult for a sufferer to fight infections. It is a highly contagious disease, through bodily fluids such as blood, semen and vaginal fluids. There is currently no cure for HIV, but there are a range of drug treatments that can allow people who are HIV positive to lead a long and full life. Antiretroviral therapy (ART) is the standard treatment for HIV, where at least three different antiretroviral (ARV) drugs are given at the same time. This treatment is very effective at supressing the virus and stopping the development of the disease. When a person has been on ART, the amount of HIV present in the blood (viral load) is reduced. After three to six months of treatment, the viral load should have fallen to undetectable levels (undetectable viral load). Currently, HIV is monitored using regular blood tests to check the viral load. This can cause patients a lot of discomfort however, as well as being time consuming and expensive. Recently, metabonomics analysis has shown promise in diagnosing diseases and monitoring drug therapy. This involves measuring the levels of chemicals that are left over after a drug has been broken down by the body (metabolites). The aim of this study is to see whether testing the amount of metabolites in urine is an effective way of monitoring of ART.
Who can participate?
HIV positive adults, currently on combination antiretroviral therapy, who have had an undetectable viral load on their last two visits to the clinic.
What does the study involve?
Ten urine samples are taken from each of the patients taking part in the study. Five of these samples are taken five days in a row, and then once every two weeks for the five remaining samples. The urine samples are then assessed in the laboratory.
What are the possible benefits and risks of participating?
There is no direct benefit for the patients involved in the study. There are no risks of participating as the urine collection is non-invasive.
Where is the study run from?
Wharfside clinic, St Mary’s Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2015 to April 2016
Who is funding the study?
1. Imperial NIHR Biomedical Research Centre (UK)
2. Institute for Translational Medicine and Therapeutics (UK)
Who is the main contact?
Dr Xinzhu Wang
xw906@imperial.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Xinzhu Wang
ORCID ID
Contact details
Jefferiss Research Trust Laboratories
Variety Wing D
2nd Floor
Wright-Fleming Institute
Faculty of Medicine
Imperial College London
St Mary's Campus
London
W2 1PG
United Kingdom
+44 20 7594 3909
xw906@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Optimising metabonomic analysis to monitor combination antiretroviral therapy efficacy in urine samples from HIV patients
Acronym
Study hypothesis
The aim of this study is to determine which platform builds the best model for assessing patient stability over a short to moderate period of time.
Ethics approval
NRES Committee London - Bromley, 04/09/2015, ref: 15/LO/1584
Study design
Single-centre observational trial
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
Ten sequential samples are taken from each patient over the course of 10 weeks. The intra-patient variability is determined in the metabolic profiling of patients who are stable on ART with undetectable viral load over a short-med period of time using using nuclear magnetic resonance spectroscopy and liquid chromatography mass spectrometry.
Intervention type
Phase
Drug names
Primary outcome measure
Urine metabonomic profiles will be measured using proton nuclear magnetic resonance spectroscopy and liquid chromatography mass spectrometry on days 1, 2, 3, 4, 5, 15, 29, 43, 57 and 71.
Secondary outcome measures
N/A
Overall trial start date
01/10/2015
Overall trial end date
01/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least 18 years of age
2. HIV positive
3. Currently taking combination antiretroviral therapy
4. Two undetectable viral loads measured in the most recent visits
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Persons who lack the capacity to consent
Recruitment start date
01/10/2015
Recruitment end date
01/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wharfside clinic
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Imperial College London
Sponsor details
Joint Research Compliance Office
Imperial College London & Imperial College Healthcare NHS Trust
5th Floor
Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 20 3311 0212
gary.roper@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Imperial NIHR Biomedical Research Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institute for Translational Medicine and Therapeutics
Alternative name(s)
ITMAT
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United States of America
Results and Publications
Publication and dissemination plan
Publication in a peer-reviewed journal.
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list