Condition category
Infections and Infestations
Date applied
16/04/2008
Date assigned
29/07/2008
Last edited
14/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Human immunodeficiency virus (HIV) attacks the immune system and weakens the body’s ability to fight infections. It can be treated with drugs that stop the virus from replicating. The aim of this study is to determine the effects of various factors on the pharmacokinetics of HIV drugs. Pharmacokinetics refers to what the body does to a drug as it moves into, through and out of the body.

Who can participate?
HIV-infected patients

What does the study involve?
Data is collected about patients in order to analyse the effect of age, weight, gender and interacting medications on the concentrations of HIV drugs in plasma (blood) samples. In addition, DNA is extracted from these plasma samples and analysed.

What are the possible benefits and risks of participating?
It is hoped that this study may help us understand why treatment response and drug levels vary in HIV patients. The data will be anonymised so that individual patients cannot be traced.

Where is the study run from?
University of Liverpool (UK)

When is the study starting and how long is it expected to run for?
October 2005 to January 2030

Who is funding the study?
British Society for Antimicrobial Chemotherapy (BSAC) (UK)

Who is the main contact?
Dr Saye Khoo
khoo@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Saye Khoo

ORCID ID

Contact details

University of Liverpool
Department of Pharmacology & Therapeutics
1st Floor
The Infirmary
70 Pembroke Place
Liverpool
L69 3GF
United Kingdom
-
khoo@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2.1

Study information

Scientific title

The Liverpool human immunodeficiency virus (HIV) therapeutic drug monitoring (TDM) registry: studying influences upon plasma human immunodeficiency virus drug exposure

Acronym

Study hypothesis

Human immunodeficiency virus (HIV) therapeutic drug monitoring (TDM) registry studying the effects of gender, body weight, age, ethnicity, interacting medication and host genetics upon pharmacokinetics of HIV drugs.

Ethics approval

Ethics approval received from the North West Multi-Regional Ethics Committee, 03/10/2005, ref: 05/MRE08/67

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Human immunodeficiency virus

Intervention

The TDM registry is a registry of patients in whom therapeutic drug monitoring has been requested for HIV drugs. Data are kept anonymised, but linked to date of birth and hospital number.

The TDM registry seeks to collate all data from patients undergoing TDM in order to analyse the effect of co-variates (age, weight, gender, concomitant medications, etc.) on concentrations of HIV drugs in plasma. In addition, DNA will be extracted from these plasma samples after second round of irreversible anonymisation, in which data relating to date of birth and hospital unit number are permanently removed so that individual patients cannot be traced. It is hoped that the ability to understand both the pharmacogenetic and the environmental influences upon HIV drug exposure may contribute to our understanding of why treatment response and drug levels are variable in HIV+ patients, particularly with respect to gender, ethnicity and host genetic influences.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Correlation between drug exposure and:
1. Age, gender, weight, disease status, interacting medications, pregnancy etc.
2. Host genomic profile (genes implicated in HIV disease process and drug disposition)

Secondary outcome measures

No secondary outcome measures.

Overall trial start date

01/10/2005

Overall trial end date

01/01/2030

Reason abandoned

Eligibility

Participant inclusion criteria

Request for TDM of HIV drugs

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

TDM requests greater than 10,000 and approximately 4000 archived plasma samples

Participant exclusion criteria

Nil. Separate filters will be applied when analysing data, e.g. for children, pregnant women, patients on dialysis, patients receiving chemotherapy etc.

Recruitment start date

01/10/2005

Recruitment end date

01/01/2030

Locations

Countries of recruitment

Ireland, Israel, United Kingdom

Trial participating centre

University of Liverpool
Liverpool
L69 3GF
United Kingdom

Sponsor information

Organisation

The University of Liverpool (UK)

Sponsor details

Research & Business Service
The Foresight Centre
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Sponsor type

University/education

Website

http://www.liv.ac.uk

Organisation

Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)

Sponsor details

Prescot Street
Liverpool
L7 8XP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.rlbuht.nhs.uk/

Funders

Funder type

Research organisation

Funder name

British Society for Antimicrobial Chemotherapy - Academic Initiative Grant (ref: PG/A1-05)

Alternative name(s)

BSAC

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18771051
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19474786
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19329800
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/192282052013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23435690
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20051929
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/198975062012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22477766
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20921307
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21364060
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/20726906
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21564164
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21441248

Publication citations

Additional files

Editorial Notes

14/03/2016: Plain English summary added. Please note that as of 14/05/2013, the overall trial end date was changed from 01/01/2011 to 01/01/2030 as the registry data will be used on an ongoing basis.