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Clinical Trials/EUCTR2011-006251-11-IT
EUCTR2011-006251-11-IT
Active, not recruiting
Not Applicable

Pilot clinical trial, controlled and randomized, Phase III, to evaluate security and efficacy of oral specific immunotherapy in HIV infected patients who suffer from grass pollen allergy.

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 sitesMarch 8, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV+ subjects with grass pollen allergy.
Sponsor
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Status
Active, not recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 8, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Eligibility Criteria

Inclusion Criteria

  • 1\) HIV\-positive adults between 18 and 60 years in HAART therapy for at least 6 months
  • 2\) Diagnosis of allergy to grass (with skin prick tests and / or RAST)
  • 3\) Diagnosis of rhinitis persistent moderate / severe according to the ARIA classification
  • 4\) Diagnosis of persistent mild intermittent asthma according GINA classification
  • 5\) CD4\> 400 stable for at least 6 months
  • 6\) VL \<37 copies of at least 6 months.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 30

Exclusion Criteria

  • 1\) Prior treatment with specific immunotherapy
  • 2\) allergy to perennial allergens (Molds, mites and animals when exposed to the animal)
  • 3\) patients with chronic diseases (infectious, autoimmunity, cancer, heart or kidney diseases) or ongoing pregnancy
  • 4\) Chronic pharmacological treatment with steroids and / or immunosuppressive
  • 5\) diseases of the oral cavity
  • 6\) serious bronchial asthma (GINA classification).

Outcomes

Primary Outcomes

Not specified

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