Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Patients who give written consent to participate in the study

• Age between 18 and 65 years old, included.

• Chronic HIV-1 Demonstration of R5 viral tropism (use of CCR5 coreceptors) by genotyping in plasma samples stored

• Patients that are to be treated with intensive chemotherapy for non Hodgkin lymphoma With or without stable antiretroviral therapy

• Patients that are able to understand the purpose of the study and be available for scheduled appointments.

• Both in the case of female and male patients, the patient agrees to use a double barrier method of contraception from the moment of signing the informed consent until 3 months after the end of their participation in the study.

Exclusion Criteria:

• To have planned antiretroviral treatment interruption during the participation in the study

• Hypersensitivity to products used in this study

• To be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation

• To have contraindications or limitations to perform leukapheresis