E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pazienti con infezione verticale da HIV di eta' compresa tra 4 -16 anni di ambo i sessi. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053500 |
E.1.2 | Term | Human immunodeficiency virus transmission |
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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 |
To document the feasibility and immunogenicity of topical HIV plasmid DNA immunization intramuscularly delivered to HIV vertically infected children. |
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E.2.2 | Secondary objectives of the trial |
1. To investigate safety of DNA plasmids carrying HIV genes intramascular delivered in HIV vertically infected children on effective PI-sparing HAART. 2. To correlate the viral load and CD4+ counts after the DNA vaccination to immune responses 3. To characterize the new HIV specific immune responses by Elispot, T-cell proliferation and antibody reactivity. 4. To investigate the possible viral escape mutants in relation to the induced immune response. 5. To study the effect on CD4 counts in the two groups |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
QUALITA DELLA VITA ALTRI SOTTOSTUDI: Tipizzazione HLA
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E.3 | Principal inclusion criteria |
1. Aged between 4 and 16 years 2. Females, who are willing not to father a child for the duration of the study. 3. Male participants will be cautioned of the unknown hazard to a foetus and advised to not have sexual relations for the duration of the study. 4. HIV infection detected by two serological and HIV plasma RNA tests 5. On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months 6. Stable CD4 value above 400 cells/mm3 or 25% in the last 12 months of follow-up 7. Viral isolate pre ART available is preferable but not mandatory 8. Able to give informed consent 9. Availability for follow-up for planned duration of the study |
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E.4 | Principal exclusion criteria |
1. Patients with ongoing infection(s) other than HIV 2. Treatment with steroids, systemic or local at the immunizing sites, one month before or during the trial 3. Patients with signs of autoimmune diseases 4. Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ml, platelets <150,000/ml 5. Patients on any immune modulating or investigational drug 6. Anamnestic allergy to kanamycin or plasmid gene products |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.1. Any grade 3 or above toxicity possibly or probably related to the immunization. 2. Virological failure defined as 2 determinations over 1000 copies/ml consecutively. 3. Immunologic failure defined as progression in the CDC classification status. 4. Clinical failure defined as progression in the CDC classification status. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |