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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-006251-11-IT
Enrollment
Unknown
Registered
2012-03-08
Start date
2012-03-19
Completion date
Unknown
Last updated
2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV+ subjects with grass pollen allergy. MedDRA version: 14.1 Level: HLGT Classification code 10001708 Term: Allergic conditions System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: ORALAIR*31CPR SUBL 100IR-300IR Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: LOLIUM PERENNE L. Current Sponsor code: NA Other descriptive name: NA Concentration unit: SU

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).—

Countries

Italy

Contacts

Public ContactS.S. Allergologia-Immunologia Clin.

Ospedale Luigi Sacco

iemoli.enrico@hsacco.it02-39042456

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026