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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status and phase: Terminated; Early Phase 1

Conditions: HIV-1 Infection

Treatments: Drug: Maraviroc

Study type: Interventional

Funder types: Other

Identifiers

NCT02486510

CHEMOMAR

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Group 1 (Control)

No Intervention group

Description:

Patients receiving intensive chemotherapy with/without stable antiretroviral therapy. Patients not receiving antiretroviral therapy will start it. Patients randomized to this group will not receive clinical trial treatment (neither Maraviroc or Placebo)

Group 2 (Treatment)

Experimental group

Description:

Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc. Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc.

Treatment:

Drug: Maraviroc