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

This study has been terminated.
(Futility criteria)
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT02486510
First received: June 24, 2015
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
HIV-1 Infection Drug: Maraviroc Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • 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) ]
    Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels


Secondary Outcome Measures:
  • Proviral DNA (copies/million cells) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Enrollment: 7
Study Start Date: July 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group 1 (Control)

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)

Experimental: Group 2 (Treatment)

Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc.

Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc.

Drug: Maraviroc

Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery.

Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours

Other Name: Celsentri

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02486510

Locations
Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  More Information

Publications:
Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02486510     History of Changes
Other Study ID Numbers: CHEMOMAR
Study First Received: June 24, 2015
Last Updated: December 17, 2015

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
HIV-1
CCR5 coreceptors
Maraviroc

Additional relevant MeSH terms:
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 27, 2017