Studio PKCT - Pharmacokinetics of chemotherapy when given concurrently with antiretroviral (Protocol no. CSL01).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023749-30-IT

Enrollment

Registered

2012-03-13

Start date

2011-10-20

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

patients with Hodgkin lymphoma and non-Hodgkin's lymphoma and HIV infection. MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: DOXORUBICINA EBEWE*1F 50MG/25M Pharmaceutical Form: Solution for injection INN or Proposed INN: Doxorubicin Concentration unit: mg milligram(s) Concentration number: 2- Trade Name: ISENTR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Age> 18 years -HIV-infection in treatment for at least 1 week with antiretroviral therapy based on two nucleoside analogues and a protease inhibitor (with or without a booster dose of ritonavir) or with a nucleoside reverse transcriptase inhibitor -NHL that requires CT as (R) HD CHOP or HD requiring CT as ABVD -HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -previous failure to raltegravir -documented resistance to raltegravir -raltegravir can't be associated with at least 2 drugs active against HIV in the class of nucleoside analogues -pregnant or nursing.

Design outcomes

Primary

Measure	Time frame
Main Objective: to study the pharmacokinetics of DX before and after the replacement of antiretroviral therapy that may alter the activity of the subunit CYP3A4 of the cytochrome p450 with raltegravir (drug that does not affect the activity of cytochrome p450).;Secondary Objective: to evaluate the toxicity of anticancer chemotherapy when administered in conjunction with a therapy that includes or does not include drugs that may modify the activity of cytochrome p450.;Primary end point(s): Area under the curve (AUC) of DX when used concomitantly with antiretroviral drugs that modify the activity of the subunits CYP3A4 of the cytochrome p450 and AUC oh DX measured after switch to raltegravir	—

Measure

Time frame

Main Objective: to study the pharmacokinetics of DX before and after the replacement of antiretroviral therapy that may alter the activity of the subunit CYP3A4 of the cytochrome p450 with raltegravir (drug that does not affect the activity of cytochrome p450).;Secondary Objective: to evaluate the toxicity of anticancer chemotherapy when administered in conjunction with a therapy that includes or does not include drugs that may modify the activity of cytochrome p450.;Primary end point(s): Area under the curve (AUC) of DX when used concomitantly with antiretroviral drugs that modify the activity of the subunits CYP3A4 of the cytochrome p450 and AUC oh DX measured after switch to raltegravir

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Countries

Italy

Outcome results

None listed

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