Evaluation of security and efficacy of immunotherapy in HIV+ patients who suffer from grass pollen allergy.

Conditions: HIV+ subjects with grass pollen allergy.
MedDRA version: 14.1Level: HLGTClassification code 10001708Term: Allergic conditionsSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-006251-11-IT

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the effects on viral load (VL) and CD4 count of oral allergy immunotherapy treatment with grass pollen, in a group of HIV-positive patients, suffering from rhino conjunctivitis persistent moderate/severe, with or without asthma, compared with a control group.;Secondary Objective: Evaluation of the effectiveness of the immunotherapy treatment by studying clinical and immunological parameters: in particular the percentage of Thelper 1 (Th1)(CD4/Tbet/IFNgamma/IL2); the percentage of Thelper 2 (Th2) (CD4/GATA3/IL4/IL10) and the percentage of Thelper 17 (Th17) (of CD4/RoRgammaT/IL17/IL21 ) circulating and allergen-specific, compared in the two groups.;Primary end point(s): Safety evaluation through the measurement of CD4 lymphocytes and HIV-RNA.;Timepoint(s) of evaluation of this end point: At study termination (4 months).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy evaluation through the measurement of immunologic markers.;Timepoint(s) of evaluation of this end point: At study termination (4 months).