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

NCT02486510 | Terminated Early Phase 1

• 1 other identifier: CHEMOMAR
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV-1 Infection

Keywords

HIV-1; CCR5 coreceptors; Maraviroc

Outcome Measures

Primary Outcomes (1)

• number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM

  Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels

  Same as chemotherapy treatment (expected average of 6 months)

Secondary Outcomes (4)

• Proviral DNA (copies/million cells)

  Same as chemotherapy treatment (expected average of 6 months)

• Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)

  Same as chemotherapy treatment (expected average of 6 months)

• Levels of HIV-1 antibodies

  Same as chemotherapy treatment (expected average of 6 months)

• Percentage of CD4+ and CD8+ cells with immune activation markers

  Same as chemotherapy treatment (expected average of 6 months)

Study Arms (2)

Group 1 (Control)

NO INTERVENTION

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

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

Interventions

Maraviroc DRUG

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

Also known as: Celsentri

Group 2 (Treatment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (2)

Hospital Universitario Ramon Y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (4)

• Wang C, Vlahov D, Galai N, Bareta J, Strathdee SA, Nelson KE, Sterling TR. Mortality in HIV-seropositive versus -seronegative persons in the era of highly active antiretroviral therapy: implications for when to initiate therapy. J Infect Dis. 2004 Sep 15;190(6):1046-54. doi: 10.1086/422848. Epub 2004 Aug 17.

  PMID: 15319852 BACKGROUND

• Moreno S, Mocroft A, Monforte Ad. Medical and societal consequences of late presentation. Antivir Ther. 2010;15 Suppl 1:9-15. doi: 10.3851/IMP1523.

  PMID: 20442456 BACKGROUND

• Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193.

  PMID: 9371822 BACKGROUND

• Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295.

  PMID: 9360927 BACKGROUND

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

ES (2)