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Sponsors and Collaborators: |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic grant from Pfizer Inc. |
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Information provided by: | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
ClinicalTrials.gov Identifier: | NCT00795444 |
The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.
Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional, since the results could provide important information on the nature of this reservoir.
If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).
The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.
Condition | Intervention | Phase |
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HIV-1 |
Drug: maraviroc |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Study Of The Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy |
Estimated Enrollment: | 10 |
Study Start Date: | March 2008 |
Arms | Assigned Interventions |
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Maraviroc: Experimental
Adult patients with HIV infection and a viral load that has been suppressed for a long period (less than 50 copies/mL for at least 2 years) while on antiretroviral therapy.The treatment group will maintain the habitual antiretroviral therapy combined with maraviroc.
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Drug: maraviroc
Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Santiago Moreno Guillen, MD,PhD | +34 913368710 | smoreno.hrc@salud.madrid.org |
Spain | |
Hospital Universitario Ramon Y Cajal | Recruiting |
MADRID, Spain, 28034 | |
Contact: Santiago Moreno Guillen, MD,PhD +34 91 336 87 10 smoreno.hrc@salud.madrid.org | |
Principal Investigator: Santiago Moreno Guillén, MD,PhD | |
Sub-Investigator: Jose Luis Casado Osorio, MD | |
Sub-Investigator: Fernando Dronda Nuñez, MD,PhD | |
Sub-Investigator: Ana Moreno Zamora, MD,PhD | |
Sub-Investigator: Maria Jesús Pérez Elias, MD,PhD | |
Sub-Investigator: Beatriz Hernández Novoa, PharmD,PhD | |
Sub-Investigator: Carolina Gutierrez Montero, PhD | |
Sub-Investigator: Rafael Rubio Garcia, MD,PhD |
Principal Investigator: | Santiago Moreno Guillen, MD,PhD | HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID |
Responsible Party: | ( Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Santiago Moreno Guillen) ) |
Study ID Numbers: | ERRADVIH-01, Eudra CT 2007-003995-21 |
Study First Received: | November 10, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00795444 |
Health Authority: | Spain: Spanish Agency of Medicines |
HIV-1 CCR5 coreceptor antagonist (Maraviroc) the cell reservoir of HIV-1 |
HIV Infections Acquired Immunodeficiency Syndrome |