Pharmacokinetic Interaction between Antiretroviral and Cytotoxic therapy in HIV-infected patients - a pilot study

Completed

• Conditions: Human Immunodeficiency Virus (HIV); lymphoma; 10025319; 10047438

• Registration Number: NL-OMON37346
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Biopsy proven lymphoma
Treated with cyclophosphamide, doxorubicin, vinblastine and/or vincristine
proven HIV positive on HAART

Exclusion Criteria

Seriously compromised peripheral venous vasculature complicating venous blood sampling
No written informed consent obtained

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serum levels of the antineoplastic and antiretroviral agents will be measured.<br /><br>Pharmacokinetic parameters will be calculated and compared to individual and<br /><br>population parameters. Clinical parameters, adverse events and if possible<br /><br>clinical outcome will be collected by laboratory values and EORTC-QLQ C30<br /><br>questionnaires and related to the collected pharmacokinetic parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>