Summary
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EudraCT Number: | 2012-004556-11 |
Sponsor's Protocol Code Number: | 2PM |
National Competent Authority: | Italy - Italian Medicines Agency |
Clinical Trial Type: | EEA CTA |
Trial Status: | Completed |
Date on which this record was first entered in the EudraCT database: | 2012-10-17 |
Trial results | View results |
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A. Protocol Information
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A.1 | Member State Concerned | Italy - Italian Medicines Agency | ||
A.2 | EudraCT number | 2012-004556-11 | ||
A.3 | Full title of the trial |
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A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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A.4.1 | Sponsor's protocol code number | 2PM | ||
A.7 | Trial is part of a Paediatric Investigation Plan | No | ||
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | OSPEDALE S. RAFFAELE DI MILANO |
B.1.3.4 | Country | Italy |
B.3.1 and B.3.2 | Status of the sponsor | Non-Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | Ministero della Salute bando Rf-2009-1526102 |
B.4.2 | Country | Italy |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | Ospedale San Raffaele |
B.5.2 | Functional name of contact point | Malattie Infettive |
B.5.3 | Address: | |
B.5.3.1 | Street Address | via Stamira D'Ancona,20 |
B.5.3.2 | Town/ city | Milano |
B.5.3.3 | Post code | 20132 |
B.5.3.4 | Country | Italy |
B.5.4 | Telephone number | 02.26437906 |
B.5.5 | Fax number | 02.26437903 |
B.5.6 | gianotti.nicola@hsr.it |
D. IMP Identification
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D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | NORVIR*FL 84CPS MOLLI 100MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ABBOTT Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Capsule, soft |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RITONAVIR |
D.3.9.1 | CAS number | 155213-67-5 |
D.3.9.4 | EV Substance Code | SUB10342MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | PREZISTA*60CPR RIV 400MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | JANSSEN CILAG SpA |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | DARUNAVIR |
D.3.9.1 | CAS number | 206361-99-1 |
D.3.9.4 | EV Substance Code | SUB25394 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 400 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 3 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | KALETRA*120CPR RIV 200MG+50MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ABBOTT Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | lopinavir/ritonavir |
D.3.9.1 | CAS number | 369372-47-4 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 500 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 4 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | TRUVADA*30CPR RIV 200MG/245MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GILEAD SCIENCES Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | emtricitabina/tenofovir |
D.3.9.1 | CAS number | 145213-48-5 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 445 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 5 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ATRIPLA*30CPR RIV600+200+245MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GILEAD SCIENCES Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | efavirenz/tenofovir/emtricitabine |
D.3.9.1 | CAS number | 143491-57-0 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 1045 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 6 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SUSTIVA*FL 30CPR RIV 600MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BRISTOL-MYERS SQUIBB Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | EFAVIRENZ |
D.3.9.1 | CAS number | 154598-52-4 |
D.3.9.4 | EV Substance Code | SUB06463MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/g milligram(s)/gram |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 600 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 7 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | REYATAZ*1FL 30CPS 300MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BRISTOL-MYERS SQUIBB Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ATAZANAVIR |
D.3.9.1 | CAS number | 198904-31-3 |
D.3.9.4 | EV Substance Code | SUB16398MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 8 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | NORVIR*FL 84CPS MOLLI 100MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ABBOTT Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Capsule, soft |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RITONAVIR |
D.3.9.1 | CAS number | 155213-67-5 |
D.3.9.4 | EV Substance Code | SUB10342MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 9 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | KALETRA*360CPR RIV 200MG+50MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ABBOTT Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | lopinavir/ritonavir |
D.3.9.1 | CAS number | 192725-17-0 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1000 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 10 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | TELZIR*1FL 60CPR RIV 700MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | VIIV HEALTHCARE Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FOSAMPRENAVIR |
D.3.9.1 | CAS number | 226700-79-4 |
D.3.9.4 | EV Substance Code | SUB25386 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 700 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | terapia antiretrovirale |
D.IMP: 11 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | KIVEXA*BL 30CPR RIV 600MG+300M |
D.2.1.1.2 | Name of the Marketing Authorisation holder | VIIV HEALTHCARE Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | lamividina e abacavir |
D.3.9.1 | CAS number | 134678-17-4 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 900 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 12 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | COMBIVIR*60CPR RIV 150MG+300MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | VIIV HEALTHCARE Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | lamivudina e zidovudina |
D.3.9.1 | CAS number | 134678-17-4 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 450 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | terapia antiretrovirale |
D.IMP: 13 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | PREZISTA*120CPR RIV 300MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | JANSSEN CILAG SpA |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | DARUNAVIR |
D.3.9.1 | CAS number | 206361-99-1 |
D.3.9.4 | EV Substance Code | SUB25394 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 14 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ISENTRESS*FL 180CPR RIV 400MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MERCK SHARP & DOHME SpA |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RALTEGRAVIR |
D.3.9.1 | CAS number | 518048-05-0 |
D.3.9.4 | EV Substance Code | SUB25667 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 800 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | terapia antiretrovirale |
D.IMP: 15 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | EMTRIVA*1FL 30CPS 200MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GILEAD SCIENCES Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Capsule, hard |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | emtricitabina |
D.3.9.1 | CAS number | 143491-57-0 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 200 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 16 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | EPIVIR*BLIST 30CPR RIV 300MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | VIIV HEALTHCARE Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | lamividina |
D.3.9.1 | CAS number | 134678-17-4 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 17 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | VIDEX*30CPS GASTR 400MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BRISTOL-MYERS SQUIBB Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | didanosina |
D.3.9.1 | CAS number | 69655-05-6 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 400 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 18 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | VIREAD*30CPR 245MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GILEAD SCIENCES Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | TENOFOVIR |
D.3.9.1 | CAS number | 147127-20-6 |
D.3.9.4 | EV Substance Code | SUB04721MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 245 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 19 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ZERIT*56CPS 40MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BRISTOL-MYERS SQUIBB Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Capsule, soft |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | stavudina |
D.3.9.1 | CAS number | 3056-17-5 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 40 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 20 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ZIAGEN*6BLISTER 10CPR 300MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | VIIV HEALTHCARE Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ABACAVIR |
D.3.9.1 | CAS number | 136470-78-5 |
D.3.9.4 | EV Substance Code | SUB07356MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 21 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | INTELENCE*FL 120CPR 100MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | JANSSEN CILAG SpA |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | etravirina |
D.3.9.1 | CAS number | 269055-15-4 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 200 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 22 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | VIRAMUNE*FL 30CPR 400MG R.P. |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BOEHRINGER INGELHEIM IT.SpA |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | nevirapina |
D.3.9.1 | CAS number | 129618-40-2 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 400 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 23 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | APTIVUS*FL 120CPS MOLLI 250MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BOEHRINGER INGELHEIM IT.SpA |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Capsule, soft |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | TIPRANAVIR |
D.3.9.1 | CAS number | 174484-41-4 |
D.3.9.4 | EV Substance Code | SUB04883MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 250 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 24 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | CELSENTRI*180CPR RIV 300MG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | VIIV HEALTHCARE Srl |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | MARAVIROC |
D.3.9.1 | CAS number | 376348-65-1 |
D.3.9.4 | EV Substance Code | SUB25224 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 600 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.8 Information on Placebo
|
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E. General Information on the Trial
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
E.1 Medical condition or disease under investigation | |||||||||||||||||
E.1.1 | Medical condition(s) being investigated |
|
|||||||||||||||
E.1.1.1 | Medical condition in easily understood language |
|
|||||||||||||||
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] | |||||||||||||||
MedDRA Classification | |||||||||||||||||
E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
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 |
|
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No | |||||||||||||||
E.3 | Principal inclusion criteria |
|
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E.4 | Principal exclusion criteria |
|
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E.5 End points | |||||||||||||||||
E.5.1 | Primary end point(s) |
|
|||||||||||||||
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
|||||||||||||||
E.5.2 | Secondary end point(s) |
|
|||||||||||||||
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
|||||||||||||||
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 | Yes | |||||||||||||||
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 | Yes | |||||||||||||||
E.6.13.1 | Other scope of the trial description |
|
|||||||||||||||
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 | No | |||||||||||||||
E.8.2.4 | Number of treatment arms in the trial | 3 | |||||||||||||||
E.8.3 | The trial involves single site in the Member State concerned | No | |||||||||||||||
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes | |||||||||||||||
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 | |||||||||||||||
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 | Yes | |||||||||||||||
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 | 24 | |||||||||||||||
E.8.9.1 | In the Member State concerned days | 0 |
F. Population of Trial Subjects
|
||||
---|---|---|---|---|
F.1 Age Range | ||||
F.1.1 | Trial has subjects under 18 | No | ||
F.1.1 | Number of subjects for this age range: | 0 | ||
F.1.1.1 | In Utero | No | ||
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No | ||
F.1.1.3 | Newborns (0-27 days) | No | ||
F.1.1.4 | Infants and toddlers (28 days-23 months) | No | ||
F.1.1.5 | Children (2-11years) | No | ||
F.1.1.6 | Adolescents (12-17 years) | No | ||
F.1.2 | Adults (18-64 years) | Yes | ||
F.1.2.1 | Number of subjects for this age range: | 295 | ||
F.1.3 | Elderly (>=65 years) | Yes | ||
F.1.3.1 | Number of subjects for this age range: | 80 | ||
F.2 Gender | ||||
F.2.1 | Female | Yes | ||
F.2.2 | Male | Yes | ||
F.3 Group of trial subjects | ||||
F.3.1 | Healthy volunteers | No | ||
F.3.2 | Patients | Yes | ||
F.3.3 | Specific vulnerable populations | Yes | ||
F.3.3.1 | Women of childbearing potential not using contraception | No | ||
F.3.3.2 | Women of child-bearing potential using contraception | Yes | ||
F.3.3.3 | Pregnant women | No | ||
F.3.3.4 | Nursing women | No | ||
F.3.3.5 | Emergency situation | No | ||
F.3.3.6 | Subjects incapable of giving consent personally | No | ||
F.3.3.7 | Others | No | ||
F.4 Planned number of subjects to be included | ||||
F.4.1 | In the member state | 375 | ||
F.5 | Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) |
|
G. Investigator Networks to be involved in the Trial
|
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N. Review by the Competent Authority or Ethics Committee in the country concerned
|
||
---|---|---|
N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2013-06-20 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
N. | Date of Ethics Committee Opinion | 2012-10-11 |
P. End of Trial
|
||
---|---|---|
P. | End of Trial Status | Completed |
P. | Date of the global end of the trial | 2015-08-03 |