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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Maraviroc
Sponsored by
ASST Fatebenefratelli Sacco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, CD4, INR, HIV-1 infection, extreme immunological compromission, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria
  • Clinica di Malattie Infettive, Policlinico, Universita' degli Studi
  • Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili
  • Divisione di Malattie Infettive, Ospedale S. Maria Annunziata
  • Clinica di Malattie Infettive, Ospedale San Martino
  • Divisione di Malattie Infettive, Ospedale San Gerardo
  • Polo di Medicina Chirurgia e Odontoiatria, Polo Didattico S. Paolo
  • U.O di Malattie Infettive, Fondazione San Raffaele del Monte Tabor
  • Divisione Clinicizzata di Malatie Infettive, Azienda Ospedaliera-Polo Universitario "Luigi Sacco"
  • I e II Divisione Malattie Infettive, Azienda Ospedaliera-Polo Universitario Luigi Sacco
  • Clinica delle Malattie Infettive, Policlinico Universitario
  • U.O. Malattie Infettive, Ospedale S. Spirito
  • Clinica delle Malattie Infettive, Policlinico Monteluce
  • Clinica delle Malattie Infettive, Policlinico "Tor Vergata"
  • III Divisione di Malattie Infettive, I.N.M.I Lazzaro Spallanzani
  • IV Divisione di Malattie Infettive, INMI Lazzaro Spallanzani
  • U.O. Malattie Infettive, Azienda Policlinico Umberto I
  • Istituto Clinica delle Malattie Infettive, Università Cattolica del Sacro Cuore
  • Clinica delle Malattie Infettive ,Ospedale Amedeo di Savoia
  • Divisione Dipartimento Urgenze Infettivologiche ad Alta Complessità e correlate all'AIDS, Ospedale Cotugno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Maraviroc

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 20, 2009
Last Updated
April 29, 2013
Sponsor
ASST Fatebenefratelli Sacco
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1. Study Identification

Unique Protocol Identification Number
NCT00884858
Brief Title
Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects
Official Title
Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Fatebenefratelli Sacco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Objectives: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, CD4, INR, HIV-1 infection, extreme immunological compromission, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maraviroc
Arm Type
Experimental
Arm Description
Subjects in this group will add Maraviroc to their current HAART.
Arm Title
2
Arm Type
No Intervention
Arm Description
Subjects in this group will continue their current HAART without adding Maraviroc.
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Maraviroc brand name in the EC is Celsentri.
Intervention Description
Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.
Primary Outcome Measure Information:
Title
CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Rusconi, M.D.
Organizational Affiliation
Universita' degli Studi di Milano, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria
City
Torrette di Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
Clinica di Malattie Infettive, Policlinico, Universita' degli Studi
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25125
Country
Italy
Facility Name
Divisione di Malattie Infettive, Ospedale S. Maria Annunziata
City
Antella
State/Province
FI
ZIP/Postal Code
50011
Country
Italy
Facility Name
Clinica di Malattie Infettive, Ospedale San Martino
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Divisione di Malattie Infettive, Ospedale San Gerardo
City
Monza
State/Province
MB
ZIP/Postal Code
20052
Country
Italy
Facility Name
Polo di Medicina Chirurgia e Odontoiatria, Polo Didattico S. Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20124
Country
Italy
Facility Name
U.O di Malattie Infettive, Fondazione San Raffaele del Monte Tabor
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
Divisione Clinicizzata di Malatie Infettive, Azienda Ospedaliera-Polo Universitario "Luigi Sacco"
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy
Facility Name
I e II Divisione Malattie Infettive, Azienda Ospedaliera-Polo Universitario Luigi Sacco
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy
Facility Name
Clinica delle Malattie Infettive, Policlinico Universitario
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
U.O. Malattie Infettive, Ospedale S. Spirito
City
Pescara
State/Province
PE
ZIP/Postal Code
65100
Country
Italy
Facility Name
Clinica delle Malattie Infettive, Policlinico Monteluce
City
Perugia
State/Province
PG
ZIP/Postal Code
06126
Country
Italy
Facility Name
Clinica delle Malattie Infettive, Policlinico "Tor Vergata"
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Facility Name
III Divisione di Malattie Infettive, I.N.M.I Lazzaro Spallanzani
City
Roma
State/Province
RM
ZIP/Postal Code
00149
Country
Italy
Facility Name
IV Divisione di Malattie Infettive, INMI Lazzaro Spallanzani
City
Roma
State/Province
RM
ZIP/Postal Code
00149
Country
Italy
Facility Name
U.O. Malattie Infettive, Azienda Policlinico Umberto I
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Clinica delle Malattie Infettive, Università Cattolica del Sacro Cuore
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Clinica delle Malattie Infettive ,Ospedale Amedeo di Savoia
City
Torino
State/Province
TO
ZIP/Postal Code
10149
Country
Italy
Facility Name
Divisione Dipartimento Urgenze Infettivologiche ad Alta Complessità e correlate all'AIDS, Ospedale Cotugno
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24244635
Citation
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.
Results Reference
derived

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

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