E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment naive HIV infected individuals |
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MedDRA Classification |
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 |
The primary objective of the trial is to compare the immunogenicity and clinical efficacy of the trial vaccine with that of placebo |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Age: Between 18 and 40 years 2. Symptom-free 3. HIV-1 positive, confirmed with WB in Finland and with the established diagnostic testing algorithm in South Africa as outlined in Appendix 3. 4. CD4 lymphocyte counts: ³0.350 x 109/L 5. No previous HAART therapy 6. Negative pregnancy test for women of child bearing potential at each study visit and a clear understanding that reliable contraception troughout the trial must be used. 7. Viral load less than 55 000 copies/ml at the screening visit.
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E.4 | Principal exclusion criteria |
1. Pregnancy or breastfeeding 2. Inability to adhere to the study protocol or attend the clinic for the required study visits 3. Persons with a history of immunotherapy < 6 months prior to entry 4. Persons receiving blood transfusion/blood products < 2 months prior to entry 5. Persons who are or need to be vaccinated with other vaccines within 8 weeks prior to or 12 weeks after the first GTU® –MultiHIV vaccination 6. Persons with history of cardiac, liver or renal disease, hypertension with complications or needing treatment with more than one drug, uncontrolled infections or intractable diarrhea 7. Persons with history of AIDS defining illness (disease stage C based on CDC classification) 8. Persons with active chronic viral hepatitis 9. Current use of intravenous drugs 10. Clinically significant abnormalities in the following labaraltory parameters: Creatinine Haemoglobin Leukocytes Platelets Triglycerides 11. Persons on any other investigational drug or vaccine trial 12. No informed consent obtained 13. Known history of kanamycin allergy
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E.5 End points |
E.5.1 | Primary end point(s) |
The cellular immunity mediated by CD8+Tcells as measured by ELISPOT IFN-gamma Humoral immunity by measuring antibodies against HIV-1 proteins
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 0 |
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 | 8 |