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

Early Phase 1

Terminated

• Conditions: HIV-1 Infection
• Interventions: Drug: Maraviroc

• Registration Number: NCT02486510
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (Treatment)	Maraviroc	Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc. Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc.

Primary Outcome Measures

Name	Time	Method
number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM	Same as chemotherapy treatment (expected average of 6 months)	Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels

Secondary Outcome Measures

Name	Time	Method
Proviral DNA (copies/million cells)	Same as chemotherapy treatment (expected average of 6 months)	Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)	Same as chemotherapy treatment (expected average of 6 months)	Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Levels of HIV-1 antibodies	Same as chemotherapy treatment (expected average of 6 months)	Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Percentage of CD4+ and CD8+ cells with immune activation markers	Same as chemotherapy treatment (expected average of 6 months)	Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels

Trial Locations

Locations (2)

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain