| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.1 | | E.1.2 | Level | 4 | | E.1.2 | Classification code | 10020161 | |
| 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 is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs.
| |
| E.2.2 | Secondary objectives of the trial | The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs.
| |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | 1. Patient has voluntarily signed the informed consent before initiation of study procedures.
2. Patient with documented HIV-1 infection.
3. Male or female patient over 18 years of age.
4. Patient has limited or no treatment options because of multiple treatment failures.
5. Negative pregnancy test for females of childbearing potential.
6. CD4 cell count ≤ 100 cells/mm3.
7. Viral load ≥ 10000 copies/mL.
| |
| E.4 | Principal exclusion criteria | 1. Primary HIV-infection.
2. Patient is eligible for other Tibotec-sponsored trials.
3. Prior or current participation to a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients).
4. Use of disallowed concomitant therapy.
5. Use of investigational medication within the last 90 days. The following exceptions apply:
- abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations;
- tipranavir; TMC114 should not be used within 14 days following the use of tipranavir. A minimal 14-day washout period is required in which tipranavir must be either interrupted or substituted to an alternative investigator selected PI regimen until baseline visit (Day 1).
6. Pregnant or breast-feeding female.
7. Female patient of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
8. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
9. Patients with the following laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (updated version form December 2004):
- Any grade 3 or 4 toxicity with the following exceptions:
- Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4.
- Patients with asymptomatic triglyceride elevations of grade 3 or 4 or cholesterol elevations ≥ grade 3.
10. Patient with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | An intent-to-treat analysis will be performed, i.e., all patients, regardless of their compliance with the protocol, are to be included in the analysis (unless no trial medication has been taken at all).
The safety and tolerability of TMC114 in combination with low dose RTV and other ARVs will be evaluated over time. Where possible, virologic and immunologic response will also be evaluated.
* Type and incidence of AEs between baseline and trial termination will be evaluated
* The ECG parameters should be described (heart rate and rhythm, PR interval, QRS interval, RR interval, if available, and QT interval).
* Vital signs include body temperature, heart rate, systolic blood pressure and diastolic blood pressure and will be evaluated.
* For the test results, laboratory abnormalities will be calculated according to the standardized DAIDS severity grading table. | |
| 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 | Yes |
| E.6.13.1 | Other scope of the trial description | | To provide early access to TMC114 | |
| 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 | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| 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.8.5 | The trial involves multiple Member States | Yes |
| 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 | |
| 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 | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
