E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | 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 |
The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC114/RTV 600/100 mg b.i.d. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are: • To evaluate the antiviral activity over time; • To evaluate the immunological effect over time. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
ORIGINAL PART OF THE TRIAL 1. Subject has signed the informed consent form voluntarily. 2. Male or female subjects aged at least 18 years. 3. Previous randomization to one of the treatment groups (including control) in the TMC114-C201, TMC114-C207 trial or in sponsor selected Phase I trials. 4. Subject agrees to take at least 2 ARVs including approved NRTIs/NtRTIs, NNRTIs, and/or T-20 in combination with the study medication (TMC114/RTV) from baseline onwards. 5. Subject can comply with the protocol requirements. 6. Subject’s general medical condition is, in the investigator’s opinion, not interfering with the assessments and the conduct of the trial. EXTENSION PART OF THE TRIAL 1. Male or female subject, 18 years and above; 2. Subject completed 96 weeks of treatment with TMC114 in the original part of the TMC114-C208 trial and TMC114 is not yet commercially available; 3. Subject has signed the informed consent form voluntary; 4. Subject can comply with the protocol requirements; 5. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the conduct of the trial.
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E.4 | Principal exclusion criteria |
ORIGINAL PART OF THE TRIAL 1. Use of disallowed concomitant therapy. 2. Use of other investigational drugs within 30 days prior to the investigational medication administration 3. Current or past history of active alcohol and/or drug use which in the investigator’s opinion would compromise the subject’s safety or compliance to the trial protocol procedures. 4. Pregnant or breast-feeding females. 5. Female subjects of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening until at least 30 days after the end of the treatment period. 6. Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections) or findings during physical examination that, in the investigator’s opinion, would compromise the subject’s safety. 7. Subject with the certain laboratory abnormalities at screening 8. Subject with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels. 9. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114/RTV). EXTENSION PART OF THE TRIAL 1. Use of disallowed concomitant therapy; 2. Pregnant or breast-feeding female; 3. Female of childbearing potential without the use of effective birth control methods from screening until at least 30 days after the end of the treatment period; 4. Any active or unstable medical condition or findings during physical examination that, in the investigator’s opinion, would compromise the subject’s safety.
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | 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
| 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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |