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

Phase 1

• Conditions: patients with Hodgkin lymphoma and non-Hodgkin's lymphoma and HIV infection.; MedDRA version: 14.1Level: LLTClassification code 10008922Term: Chronic infection with HIVSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-023749-30-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-13
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3

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 <50 copies / ml.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

-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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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