Condition category
Infections and Infestations
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
01/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helen Reynolds

ORCID ID

Contact details

Room 4.394
The Duncan Building
Royal Liverpool Hospital
Daulby Street
Liverpool
L69 3GA
United Kingdom
-
her@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7342

Study information

Scientific title

Host genetic factors influencing drug disposition and response to human immunodeficiency virus treatment

Acronym

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

North West MREC (now changed to North West 5 Research Ethics Committee), 07/11/2003, ref: 02/8/87

Study design

Multicentre non-randomised observational treatment cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Phase

Phase IV

Drug names

Primary outcome measures

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 trial start date

24/04/2007

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 900

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

United Kingdom

Trial participating centre

Royal Liverpool Hospital
Liverpool
L69 3GA
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
United Kingdom
-
research@rlbuht.nhs.uk

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

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes