Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects

NCT00884858 | Completed Phase 4

• 1 other identifier: HLS/MVC01/2008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 20

Brief Summary

Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed. 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.

Conditions

HIV Infections

Keywords

HIV-1; CD4; INR; HIV-1 infection; extreme immunological compromission; treatment experienced

Outcome Measures

Primary Outcomes (1)

• CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.

  3 and 12 months

Study Arms (2)

Maraviroc

EXPERIMENTAL

Subjects in this group will add Maraviroc to their current HAART.

Drug: Maraviroc

2

NO INTERVENTION

Subjects in this group will continue their current HAART without adding Maraviroc.

Interventions

Maraviroc DRUG

Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.

Also known as: Maraviroc brand name in the EC is Celsentri.

Maraviroc

Eligibility Criteria

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

You may qualify if:

• age \> or = 18
• 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

You may not qualify if:

• allergy/intolerance to the study drug
• 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

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (20)

Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria

Torrette Di Ancona, AN, 60126, Italy

Location

Clinica di Malattie Infettive, Policlinico, Universita' degli Studi

Bari, BA, 70124, Italy

Location

Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili

Brescia, BS, 25125, Italy

Location

Divisione di Malattie Infettive, Ospedale S. Maria Annunziata

Antella, FI, 50011, Italy

Location

Clinica di Malattie Infettive, Ospedale San Martino

Genova, GE, 16132, Italy

Location

Divisione di Malattie Infettive, Ospedale San Gerardo

Monza, MB, 20052, Italy

Location

Polo di Medicina Chirurgia e Odontoiatria, Polo Didattico S. Paolo

Milan, MI, 20124, Italy

Location

U.O di Malattie Infettive, Fondazione San Raffaele del Monte Tabor

Milan, MI, 20132, Italy

Location

Divisione Clinicizzata di Malatie Infettive, Azienda Ospedaliera-Polo Universitario "Luigi Sacco"

Milan, MI, 20157, Italy

Location

I e II Divisione Malattie Infettive, Azienda Ospedaliera-Polo Universitario Luigi Sacco

Milan, MI, 20157, Italy

Location

Clinica delle Malattie Infettive, Policlinico Universitario

Modena, MO, 41100, Italy

Location

Divisione Dipartimento Urgenze Infettivologiche ad Alta Complessità e correlate all'AIDS, Ospedale Cotugno

Napoli, Napoli, 80131, Italy

Location

U.O. Malattie Infettive, Ospedale S. Spirito

Pescara, PE, 65100, Italy

Location

Clinica delle Malattie Infettive, Policlinico Monteluce

Perugia, PG, 06126, Italy

Location

Clinica delle Malattie Infettive, Policlinico "Tor Vergata"

Roma, RM, 00133, Italy

Location

III Divisione di Malattie Infettive, I.N.M.I Lazzaro Spallanzani

Roma, RM, 00149, Italy

Location

IV Divisione di Malattie Infettive, INMI Lazzaro Spallanzani

Roma, RM, 00149, Italy

Location

U.O. Malattie Infettive, Azienda Policlinico Umberto I

Roma, RM, 00161, Italy

Location

Istituto Clinica delle Malattie Infettive, Università Cattolica del Sacro Cuore

Roma, RM, 00168, Italy

Location

Clinica delle Malattie Infettive ,Ospedale Amedeo di Savoia

Torino, TO, 10149, Italy

Location

Related Publications (1)

• 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.

  PMID: 24244635 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stefano Rusconi, M.D.

  Universita' degli Studi di Milano, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher/Aggregate professor in infectious diseases

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

IT (20)