E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV+ subjects with grass pollen allergy. |
soggetti HIV+ con allergia alle graminacee. |
|
E.1.1.1 | Medical condition in easily understood language |
grass pollen allergy. |
allergia alle graminacee. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10001708 |
E.1.2 | Term | Allergic conditions |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Valutazione degli effetti sulla carica virale (VL) e sulla conta dei CD4 del trattamento con immunoterapia antiallergica orale per graminacee, in un gruppo di pazienti HIV positivi affetti da rinocongiuntivite persistente moderata/grave, con o senza asma, rispetto ad un gruppo di controllo. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Valutazione dell’efficacia del trattamento con immunoterapia antiallergica orale per graminacee attraverso lo studio, nei due gruppi, di parametri clinici e di alcuni paramentri immunologici, quali:
la percentuale dei T helper 1 (Th1)(CD4/Tbet/IFNgamma/IL2); dei T helper 2 (Th2) (CD4/GATA3/IL4/IL10) e dei T helper 17 (Th17) (CD4/RoRgammaT/IL17/IL21) circolanti e allergene-specifici. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1) Adulti HIV positivi compresi tra i 18 ed i 45 anni in terapia HAART efficace da almeno 6 mesi
2) Diagnosi di allergia a graminacee (con prick test e/o con RAST)
3) Diagnosi di rinite persistente moderata/severa secondo la classificazione ARIA
4) Diagnosi di asma intermittente lieve persistente (classificazione GINA)
5) CD4 >400 stabili da almeno 6 mesi
6) CV <37 copie/ml da almeno 6 mesi. |
|
E.4 | Principal 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). |
1) Precedenti trattamenti con immunoterapia specifica
2) allergia ad allergeni perenni (micofiti, acari ed animali se esposti all’animale)
3) pazienti affetti da malattie croniche (infettive, oncologiche autoimmuni, cardiache o renali)-gravidanza in atto
4) trattamenti farmacologici cronici con steroidi e/o immunosoppressori
5) malattie del cavo orale
6) Asma bronchiale di tipo grave (classificazione GINA). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety evaluation through the measurement of CD4 lymphocytes and HIV-RNA. |
Valutazione della sicurezza mediante la misurazione dei linfociti CD4 e HIV-RNA. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At study termination (4 months). |
Al termine dello studio (4 mesi). |
|
E.5.2 | Secondary end point(s) |
Efficacy evaluation through the measurement of immunologic markers. |
Valutazione dell'efficacia mediante la misurazione dei parametri immunologici. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At study termination (4 months). |
Al termine dello studio (4 mesi). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
antistaminici/corticosteroidi. |
antihistamimes/steroids. |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |