Pharmacogenetics of human immunodeficiency virus therapy

ISRCTN	ISRCTN81110147
DOI	https://doi.org/10.1186/ISRCTN81110147
Secondary identifying numbers	7342

Submission date: 28/05/2010
Registration date: 28/05/2010
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Miss Helen Reynolds
Scientific

Room 4.394, The Duncan Building
Royal Liverpool Hospital
Daulby Street
Liverpool
L69 3GA
United Kingdom

Email	her@liv.ac.uk

Study information

Study design	Multicentre non-randomised observational treatment cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Host genetic factors influencing drug disposition and response to human immunodeficiency virus treatment
Study hypothesis	This is a study to investigate the association between genetic polymorphisms and: 1. Treatment response (viral load and CD4 count), or 2. Drug exposure in human immunodeficiency virus (HIV) positive patients The cohort study examines treatment response after starting or switching antiretroviral therapy (ART) regimen according to genotype. There is also a cross-sectional study where the primary endpoint is the measured concentration of antiviral drug. The relationship between drug exposure and genetic polymorphism will also be examined. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7342
Ethics approval(s)	North West MREC (now changed to North West 5 Research Ethics Committee), 07/11/2003, ref: 02/8/87
Condition	Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
Intervention	Study A: This study is examining treatment response after starting or switching antiretroviral therapy according to genotype with the primary endpoint of a change in CD4 count and viral load at 24 weeks. Study B: This study involves obtaining a single blood sample in which drug concentrations will be measured. The primary endpoint is the measurement of the antiretroviral drug. Genomic DNA will be purified and quantified from both studies. Genetic polymorphisms will be defined by PCR-RFLP, sequence-specific PCR or SNaPshot as optimised for each allele to be examined.
Intervention type	Other
Primary outcome measure	Change in CD4 count and viral load, measured at 24 weeks, with secondary endpoints of viral load at 12 weeks and time to/proportion achieving undetectable viral load
Secondary outcome measures	1. Change in viral load at 12 weeks 2. Time to/proportion achieving undetectable viral load
Overall study start date	24/04/2007
Overall study end date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 900
Participant inclusion criteria	Study A: Recruitment from existing cohort studies Study B: 1. Aged greater than 18 years 2. Know HIV-seropositive 3. Receiving antiretroviral therapy 4. Having drug concentration measured
Participant exclusion criteria	Study A: Recruitment from existing cohort studies Study B: 1. Aged less than 18 years 2. Not on antiretroviral therapy
Recruitment start date	24/04/2007
Recruitment end date	31/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Liverpool Hospital

Liverpool
L69 3GA
United Kingdom

Sponsor information

University of Liverpool (UK)
University/education

Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
England
United Kingdom

Email	research@rlbuht.nhs.uk
Website	http://www.liv.ac.uk/

Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)
Hospital/treatment centre

Prescot Street
Liverpool
L7 8XP
England
United Kingdom

University of Liverpool
Not defined

Website	http://www.liv.ac.uk/
"ROR"	https://ror.org/04xs57h96

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
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	01/11/2008	21/01/2019	Yes	No
Results article	results	01/02/2014	21/01/2019	Yes	No
Results article	results	01/05/2009	21/01/2019	Yes	No
Results article	results of population pharmacokinetic modeling of the association between 63396C->T pregnane X receptor polymorphism and unboosted atazanavir clearance	01/12/2010	21/01/2019	Yes	No
Results article	results of the association of ABCC10 polymorphisms with nevirapine plasma concentrations	01/01/2012	21/01/2019	Yes	No
Results article	results of the effect of SLCO1B1 polymorphisms on lopinavir plasma concentration in HIV-infected adults	01/02/2012	21/01/2019	Yes	No
Results article	results of the effects of SNPs within OATP1A2, OATP1B1 and OATP1B3 on the pharmacokinetics of lopinavir	01/02/2010	21/01/2019	Yes	No

Editorial Notes

21/01/2019: Publication references added
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.