The Liverpool human immunodeficiency virus (HIV) therapeutic drug monitoring (TDM) registry
| ISRCTN | ISRCTN65117827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65117827 |
| Secondary identifying numbers | Version 2.1 |
- Submission date
- 16/04/2008
- Registration date
- 29/07/2008
- Last edited
- 21/09/2021
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
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
Contact information
Scientific
University of Liverpool
Department of Pharmacology & Therapeutics
1st Floor, The Infirmary
70 Pembroke Place
Liverpool
L69 3GF
United Kingdom
| khoo@liv.ac.uk |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | The Liverpool human immunodeficiency virus (HIV) therapeutic drug monitoring (TDM) registry: studying influences upon plasma human immunodeficiency virus drug exposure |
| 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(s) | Ethics approval received from the North West Multi-Regional Ethics Committee, 03/10/2005, ref: 05/MRE08/67 |
| 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 |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Overall study end date | 01/01/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | TDM requests greater than 10,000 and approximately 4000 archived plasma samples |
| Participant inclusion criteria | Request for TDM of HIV drugs |
| 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
- England
- Ireland
- Israel
- United Kingdom
Study participating centre
L69 3GF
United Kingdom
Sponsor information
University/education
Research & Business Service
The Foresight Centre
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
| Website | http://www.liv.ac.uk |
|---|---|
"ROR" |
https://ror.org/04xs57h96 |
Hospital/treatment centre
Prescot Street
Liverpool
L7 8XP
England
United Kingdom
| Website | http://www.rlbuht.nhs.uk/ |
|---|---|
|
"ROR" |
https://ror.org/009sa0g06 |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BSAC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No | |
| Results article | results | 01/05/2009 | Yes | No | |
| Results article | results | 01/06/2009 | Yes | No | |
| Results article | results | 01/08/2009 | Yes | No | |
| Results article | results | 01/01/2010 | Yes | No | |
| Results article | results | 01/02/2010 | Yes | No | |
| Results article | results | 01/12/2010 | Yes | No | |
| Results article | results | 01/01/2011 | Yes | No | |
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/06/2011 | Yes | No | |
| Results article | results | 01/06/2011 | Yes | No |
Editorial Notes
21/09/2021: Internal review.
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.
