Clinical trial NCT02486510: Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication
Official title: Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: HIV-1 Infection
Keywords: HIV-1
CCR5 coreceptors
Maraviroc
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
timeFrame: Same as chemotherapy treatment (expected average of 6 months)
Secondary outcomes:
measure: Proviral DNA (copies/million cells)
timeFrame: Same as chemotherapy treatment (expected average of 6 months)
measure: Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)
timeFrame: Same as chemotherapy treatment (expected average of 6 months)
measure: Levels of HIV-1 antibodies
timeFrame: Same as chemotherapy treatment (expected average of 6 months)
measure: Percentage of CD4+ and CD8+ cells with immune activation markers
timeFrame: Same as chemotherapy treatment (expected average of 6 months)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
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. doi: 10.1086/422848. Epub 2004 Aug 17.
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.
citation: 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.
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. doi: 10.1126/science.278.5341.1295.