Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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 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

Trial website

Contact information



Primary contact

Dr Xinzhu Wang


Contact details

Jefferiss Research Trust Laboratories
Variety Wing D
2nd Floor
Wright-Fleming Institute
Faculty of Medicine
Imperial College London
St Mary's Campus
W2 1PG
United Kingdom
+44 20 7594 3909

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Optimising metabonomic analysis to monitor combination antiretroviral therapy efficacy in urine samples from HIV patients


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


Secondary study design

Case series

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Human immunodeficiency virus (HIV)


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



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


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Participant exclusion criteria

Persons who lack the capacity to consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


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
W6 8RF
United Kingdom
+44 20 3311 0212

Sponsor type




Funder type

Research organisation

Funder name

Imperial NIHR Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Institute for Translational Medicine and Therapeutics

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)


United States of America

Results and Publications

Publication and dissemination plan

Publication in a peer-reviewed journal.

Intention to publish date


Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

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.