(Maraviroc ENHancement of Immunological Response): A pilot study of maraviroc as an add-on in patients with reduced CD4 cell count despite full viral suppression - MENHIR

• Conditions: HIV; MedDRA version: 9.1Level: HLTClassification code 10052740

• Registration Number: EUCTR2010-019518-25-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-13
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

i. Age > 18 years
ii. Informed consent signed (add. 1)
iii. Patients with a reduced CD4 cell count (<250 cells/mmc) response to HAART despite full viral suppression (HIV-RNA <50 copies/ml) for at least 6 months.
iv. Stable HAART for least 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
ii. Any ongoing grade 4 (WHO) AE or laboratory abnormality.
iii. Allergy/intolerance to the study drug
iv. Treatment with immunomodulatory agents
v. Treatment with steroids
vi. Radiotherapy or chemotherapy
vii. HAART consisting of a combination of tenofovir and didanosine
viii. Autoimmune disorder or chronic inflammatory disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified