E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Human Immunodeficiency Virus (HIV-1) infection |
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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 | 10008919 |
E.1.2 | Term | Chronic HIV infection |
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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 |
1) To assess the safety of 48 weeks of 10 mg once daily (QD) of elvucitabine therapy with background antiretroviral therapy in HIV-1-infected subjects who have completed 14 days of treatment in Protocol ACH443-014A
2) To describe the antiviral activity as measured by plasma HIV-1 RNA levels of 10 mg QD of elvucitabine, plus background antiretroviral therapy over 48 weeks in HIV-1-infected subjects who have completed 14 days of treatment in Protocol ACH443-014A
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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 |
Subjects who have safely completed 14 days of treatment in ACH443-014A and who remain candidates to receive elvucitabine together with background antiretroviral therapy as defined by non-clinically significant changes in the subject’s hematologic and chemistry profiles or absence of any clinical condition that, in the investigator’s opinion, would make them unsuitable for the study or unable to comply with the dosing.
Subjects must also continue to meet requirements regarding contraception to prevent pregnancy as defined in Section 5.6 of the protocol. |
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E.4 | Principal exclusion criteria |
Subjects who no longer remain candidates to receive elvucitabine together with background antiretroviral therapy as defined by non-clinically significant changes in the subject’s hematologic and chemistry profiles or presence of any clinical condition that, in the investigator’s opinion, would make them unsuitable for the study or unable to comply with the dosing.
Subjects who fail to meet requirements regarding contraception to prevent pregnancy as defined in Section 5.6 of the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy will be described using data on HIV-1 RNA levels as collected for the duration of the subject's enrollment in this extension study. An HIV genotype and phenotype profile will be obtained at Week 24 of the study and at the conclusion of elvucitabine therapy.
Safety evaluation will take into account the recorded treatment-emergent AEs, clinical laboratory safety tests, physical examinations, vital signs and any other parameter that is relevant for safety assessment. The term "adverse event" includes any adverse reaction associated with the use of the investigational product. |
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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 | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 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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Last visit of last subject |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |