Status:
COMPLETED
Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects
Lead Sponsor:
ASST Fatebenefratelli Sacco
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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% compar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00884858
Start Date
April 1 2009
End Date
April 1 2011
Last Update
April 30 2013
Active Locations (20)
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1
Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria
Torrette Di Ancona, AN, Italy, 60126
2
Clinica di Malattie Infettive, Policlinico, Universita' degli Studi
Bari, BA, Italy, 70124
3
Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili
Brescia, BS, Italy, 25125
4
Divisione di Malattie Infettive, Ospedale S. Maria Annunziata
Antella, FI, Italy, 50011