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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT02486510
• Date of registration: 24/06/2015
• Prospective Registration: No
• Primary sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Public title: Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication CHEMOMAR
• Scientific title: Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication
• Date of first enrolment: July 2012
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02486510
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 0

Countries of recruitment

Spain

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Drug: Maraviroc

Primary Outcome(s)

number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM [Time Frame: Same as chemotherapy treatment (expected average of 6 months)]

Secondary Outcome(s)

Proviral DNA (copies/million cells) [Time Frame: Same as chemotherapy treatment (expected average of 6 months)]

Levels of HIV-1 antibodies [Time Frame: Same as chemotherapy treatment (expected average of 6 months)]

Effector T cells producing HIV-1 specific gamma interferon (cells/mm3) [Time Frame: Same as chemotherapy treatment (expected average of 6 months)]

Percentage of CD4+ and CD8+ cells with immune activation markers [Time Frame: Same as chemotherapy treatment (expected average of 6 months)]

Secondary ID(s)

CHEMOMAR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors