The Liverpool HIV TDM Registry: Studying influences upon plasma HIV drug exposure - The Liverpool HIV TDM Registry

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006076-38-GB

Enrollment

12000

Registered

2007-04-17

Start date

2007-04-26

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacogenetic 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.

Interventions

Trade Name: Protease inhibitors Product Name: Protease inhibitor Pharmaceutical Form: Capsule* INN or Proposed INN: INDINAVIR CAS Number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Samples held in the TDM Registry archive Anonymised as per protocol Are the trial subjects under 18? yes 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

Exclusion criteria: Sample not held in TDM Registry archive

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Primary end point(s): Correlation between genotype and drug exposure; Main Objective: To investigate the association between genetic polymorphisms and a) treatment response (viral load and CD4 count), or b) drug exposure in HIV+ patients. A candidate gene approach will be utilised to examine the following loci of interest: Drug metabolism e.g. CYP P450- 2C9, 2D6 and 2C19 Drug transporters e.g. MDR1 (P-gp), MRP-1, MRP-2, MRP-5 Protein binding e.g. ORM1 Other candidate genes will emerge as genetic polymorphisms are characterised - these include other drug transporter and metabolising enzymes, and their effect on drug efficacy as well as drug toxicity.	—

Measure

Time frame

Secondary Objective: ;Primary end point(s): Correlation between genotype and drug exposure; Main Objective: To investigate the association between genetic polymorphisms and a) treatment response (viral load and CD4 count), or b) drug exposure in HIV+ patients. A candidate gene approach will be utilised to examine the following loci of interest: Drug metabolism e.g. CYP P450- 2C9, 2D6 and 2C19 Drug transporters e.g. MDR1 (P-gp), MRP-1, MRP-2, MRP-5 Protein binding e.g. ORM1 Other candidate genes will emerge as genetic polymorphisms are characterised - these include other drug transporter and metabolising enzymes, and their effect on drug efficacy as well as drug toxicity.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026