Host genetic factors influencing drug disposition and response to HIV treatment - Pharmacogenetics of HIV Therapy

Phase 1

• Conditions: Pharmacogeneric study of HIV+ patients receiving antiretroviral therapy. We wish to correlate drug concentration with host genetic patients receiving certain HIV drugs. No dosage modification will be carried out and choice of antiretroviral and their dosing will not be influenced by participation in this study.

• Registration Number: EUCTR2006-003425-81-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

age > 18 years
known HIV-seropositive
either starting or switching antiretroviral regimen (with viral load and CD4 count at 24 weeks),
or receiving antiretroviral therapy >2 weeks, and having drug concentration measured.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusionage < 18 years
not receiving anti-retroviral therapy

Written informed consent will be required for all subjects enrolled and a separate section will be utilised to request additional consent to store DNA for future studies, in line with published guidelines [27]. Each subject will be assigned a unique identification code which will be anonymously linked to the following clinical data to be collected:

•all subjects: age, gender, ethnic group, clinical stage of disease, pre-existing liver impairment,
development of any drug toxicity, development of any clinical event, record of all
medications (including doses prescribed),
plus
•STUDY Achange in CD4 count & viral load at 24 weeks, previous ART exposure
•STUDY BCD4 count, viral load, reason for requesting TDM,

Genomic DNA will be purified and quantified from stored samples by standard phenol-chloroform extraction methods. It is envisaged that a single sample (originating from ~10mL of blood) will yield sufficient ( ? 100?g) quantities of DNA for analysis and storage. Genetic polymorphisms will be defined by PCR-RFLP, sequence-specific PCR, or SNaPshot as optimised for each allele to be examined.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified