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

HIV-1 Infection Clinical Trial

— CHEMOMAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02486510
• Other study ID #: CHEMOMAR
• Status: Terminated
• Phase: Early Phase 1
• First received: June 24, 2015
• Last updated: December 17, 2015
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2004 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proviral DNA (copies/million cells)	Secondary 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	Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)	Secondary 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	Levels of HIV-1 antibodies	Secondary 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	Percentage of CD4+ and CD8+ cells with immune activation markers	Secondary 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)