E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 provide continued access to TMC278 for subjects who were randomized and treated with TMC278 in the Phase IIb (C204) or Phase III trials (C209 and C215), and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from TMC278 treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the long-term safety and tolerability of TMC278 25 mg q.d. in combination with a background regimen containing 2 N(t)RTIs. Available efficacy data will also be collected,including resistance data in case of virologic failure. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible, subjects must satisfy all of the following criteria:
1. Male or female subjects, aged 18 years or older.
2. Subjects must have signed an informed consent form (ICF) indicating that they are willing to participate in the trial and understand the purpose and procedures required for the trial.
3. Subjects are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol defined treatment period.
4. Subjects benefit from treatment with TMC278, according to the efficacy and safety criteria as set out in the previous protocol, and will continue to benefit from this treatment in the opinion of the investigator.
5. Subjects can comply with the current protocol requirements.
6. The subject's general medical condition, in the investigator's opinion, does not interfere with participation in the trial. |
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E.4 | Principal exclusion criteria |
Potential subjects who meet any of the following criteria will be excluded from participating in
the trial:
1. Use of disallowed concomitant therapy (see Section 8).
2. Females of childbearing potential* who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).
Effective birth control methods**:
(1) male condom *** in combination with diaphragm or cervical cap ****(“double barrier method”),
(2) intrauterine device or hormonal contraceptive, in combination with a barrier contraceptive (i.e., male or female condom***, diaphragm, or cervical cap****),
(3) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner, if no other effective birth control methods are being used, vasectomy should have been performed more than 1 month prior to withdrawal of these other effective birth control methods..
* Women who are postmenopausal for at least 2 years, women with total hysterectomy and women who have a bilateral tubal ligation are considered of non-childbearing potential.
** Spermicides should not be used as this can potentially increase the rate of HIV-1 transmission.
** a male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
**** A cervical cap has been shown to be less effective in parous women. Therefore, this barrier method is preferably not used in parous women in this trial.
3. Non-vasectomized heterosexually active male subjects without the use of effective birth control methods or not willing to continue practicing these birth control methods
during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278). |
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E.5 End points |
E.5.1 | Primary end point(s) |
- provide continued access to TMC278 for subjects who were randomized and treated with TMC278 in the Phase IIb (C204) or Phase III trials (C209 and C215)
- evaluate the long-term safety and tolerability of TMC278 25 mg q.d. in combination with a background regimen containing 2 N(t)RTIs. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
HIV RNA levels and CD4+ cells |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 74 |
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 | No |
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 | 6 |
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 | 6 |