A novel urine test to monitor antiretroviral treatment efficacy in HIV patients

ISRCTN ISRCTN10430191
DOI https://doi.org/10.1186/ISRCTN10430191
Secondary identifying numbers N/A
Submission date
18/09/2015
Registration date
28/10/2015
Last edited
11/06/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 December 2020 (updated 11/06/2019, previously: 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

Contact information

Dr Xinzhu Wang
Scientific

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

Phone +44 20 7594 3909
Email xw906@imperial.ac.uk

Study information

Study designSingle-centre observational trial
Primary study designObservational
Secondary study designCase series
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOptimising metabonomic analysis to monitor combination antiretroviral therapy efficacy in urine samples from HIV patients
Study objectivesThe 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(s)NRES Committee London - Bromley, 04/09/2015, ref: 15/LO/1584
Health condition(s) or problem(s) studiedHuman immunodeficiency virus (HIV)
InterventionTen 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 typeOther
Primary outcome measureUrine 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 measuresN/A
Overall study start date01/10/2015
Completion date31/12/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. 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
Key exclusion criteriaPersons who lack the capacity to consent
Date of first enrolment01/10/2015
Date of final enrolment01/04/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wharfside clinic
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Sponsor information

Imperial College London
University/education

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
England
United Kingdom

Phone +44 20 3311 0212
Email gary.roper@imperial.ac.uk
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Research organisation

Imperial NIHR Biomedical Research Centre

No information available

Institute for Translational Medicine and Therapeutics
Private sector organisation / Universities (academic only)
Alternative name(s)
ITMAT
Location
United States of America

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPublication in a peer-reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

11/06/2019: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2018 to 31/12/2020.
2. The overall end date was changed from 01/04/2016 to 31/12/2020.
3. The plain English summary was updated to reflect these changes.
31/05/2018: The intention to publish date has been changed from 31/05/2016 to 31/12/2018.
31/05/2018: No publications found, verifying study status with principal investigator.
31/03/2016: Ethics approval information added.