Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects
NCT ID: NCT00884858
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2009-04-30
2011-04-30
Brief Summary
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Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution.
Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur.
Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.
With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.
Detailed Description
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* Evaluate the clinical efficacy of HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells \< 25% compared to the HAART initiation and with a complete and stable virologic suppression after 12 months of HAART. Patients could also being included if their CD4 slope has been stable without any improvement, with an absolute value around 200 cells/uL.
* Evaluate the effects of HAART intensification with MVC on the modification of immunologic and virologic parameters.
* Evaluate the tolerability of HAART intensification with MVC and the appearance of drug-related side effects.
Design:
This will be a randomised, multicenter, study that will evaluate HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells \< 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maraviroc
Subjects in this group will add Maraviroc to their current HAART.
Maraviroc
Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.
2
Subjects in this group will continue their current HAART without adding Maraviroc.
No interventions assigned to this group
Interventions
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Maraviroc
Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV-Abs positivity detected by ELISA and confirmed by Western-Blot
* CD4 lymphocytes \< 200/uL and/or CD4 recovery \< 25% after at least 12 months of stable HAART
* HIV-RNA \< 50 cp/mL during the last 12 months
* negative pregnancy test at least 14 days prior to treatment
* understanding and signing the informed consent
Exclusion Criteria
* less than 1 year from any treatment with immunomodulatory agents
* current OIs or neoplasms
* current CVD or EKG abnormalities
* current respiratory tract diseases or COPD
* treatment with steroids within 4 weeks from treatment beginning
* suspect of autoimmune disorder or chronic inflammatory disease
* active IVDUs or alcohol addicts
* AST and ALT \> 2.5 ULD
* serum creatinine \> 1.5 ULD
* ANC \< 1000/uL
* hemoglobin \< 10 g/dL
* platelets \< 75.000/uL
* reticulocytes \> 2%
* Karnofsky score \< 50
18 Years
ALL
No
Sponsors
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ASST Fatebenefratelli Sacco
OTHER
Responsible Party
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Stefano Rusconi
Researcher/Aggregate professor in infectious diseases
Principal Investigators
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Stefano Rusconi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universita' degli Studi di Milano, Italy
Locations
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Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria
Torrette Di Ancona, AN, Italy
Clinica di Malattie Infettive, Policlinico, Universita' degli Studi
Bari, BA, Italy
Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili
Brescia, BS, Italy
Divisione di Malattie Infettive, Ospedale S. Maria Annunziata
Antella, FI, Italy
Clinica di Malattie Infettive, Ospedale San Martino
Genova, GE, Italy
Divisione di Malattie Infettive, Ospedale San Gerardo
Monza, MB, Italy
Polo di Medicina Chirurgia e Odontoiatria, Polo Didattico S. Paolo
Milan, MI, Italy
U.O di Malattie Infettive, Fondazione San Raffaele del Monte Tabor
Milan, MI, Italy
Divisione Clinicizzata di Malatie Infettive, Azienda Ospedaliera-Polo Universitario "Luigi Sacco"
Milan, MI, Italy
I e II Divisione Malattie Infettive, Azienda Ospedaliera-Polo Universitario Luigi Sacco
Milan, MI, Italy
Clinica delle Malattie Infettive, Policlinico Universitario
Modena, MO, Italy
Divisione Dipartimento Urgenze Infettivologiche ad Alta Complessità e correlate all'AIDS, Ospedale Cotugno
Napoli, Napoli, Italy
U.O. Malattie Infettive, Ospedale S. Spirito
Pescara, PE, Italy
Clinica delle Malattie Infettive, Policlinico Monteluce
Perugia, PG, Italy
Clinica delle Malattie Infettive, Policlinico "Tor Vergata"
Roma, RM, Italy
III Divisione di Malattie Infettive, I.N.M.I Lazzaro Spallanzani
Roma, RM, Italy
IV Divisione di Malattie Infettive, INMI Lazzaro Spallanzani
Roma, RM, Italy
U.O. Malattie Infettive, Azienda Policlinico Umberto I
Roma, RM, Italy
Istituto Clinica delle Malattie Infettive, Università Cattolica del Sacro Cuore
Roma, RM, Italy
Clinica delle Malattie Infettive ,Ospedale Amedeo di Savoia
Torino, TO, Italy
Countries
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References
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Rusconi S, Vitiello P, Adorni F, Colella E, Foca E, Capetti A, Meraviglia P, Abeli C, Bonora S, D'Annunzio M, Di Biagio A, Di Pietro M, Butini L, Orofino G, Colafigli M, d'Ettorre G, Francisci D, Parruti G, Soria A, Buonomini AR, Tommasi C, Mosti S, Bai F, Di Nardo Stuppino S, Morosi M, Montano M, Tau P, Merlini E, Marchetti G. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial. PLoS One. 2013 Nov 14;8(11):e80157. doi: 10.1371/journal.pone.0080157. eCollection 2013.
Other Identifiers
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HLS/MVC01/2008
Identifier Type: -
Identifier Source: org_study_id