Condition category
Infections and Infestations
Date applied
18/09/2015
Date assigned
28/10/2015
Last edited
31/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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 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 metabonimic 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 measures

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

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

31/05/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/03/2016: Ethics approval information added.