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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37346
Enrollment
10
Registered
2012-03-26
Start date
2013-03-25
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Human Immunodeficiency Virus (HIV) lymphoma

Interventions

None listed

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Serum levels of the antineoplastic and antiretroviral agents will be measured. Pharmacokinetic parameters will be calculated and compared to individual and population parameters. Clinical parameters, adverse events and if possible clinical outcome will be collected by laboratory values and EORTC-QLQ C30 questionnaires and related to the collected pharmacokinetic parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)