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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020192 |
E.1.2 | Term | HIV-1 |
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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 TMC125. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the antiviral activity and immunologic effect of TMC125 as part of an antiretroviral therapy over time, and to evaluate the genotypic and phenotypic changes over time.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A substudy of TMC125-C229 to evaluate the pharmacokinetics of TMC125 as formulation TF035 and formulation F060 at steady-state in HIV-1 infected subjects. (version 1.0, 16 September 2005)
The objective of the substudy is to compare the pharmacokinetic profiles of TMC125 800 mg b.i.d. formulation TF035 and 200 mg b.i.d. formulation F060 in the same subjects at steady-state. |
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E.3 | Principal inclusion criteria |
Subjects who meet all of the following criteria are eligible for this trial: 1. subject voluntarily signed the informed consent ; 2. subject was previously randomized to a TMC125 treatment arm and completed at least 48 weeks of treatment with TMC125. 3. subject can comply with the protocol requirements; 4. subject's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. |
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E.4 | Principal exclusion criteria |
Subjects meeting one or more of the following criteria cannot be selected: 1. use of disallowed concomitant therapy unless prior exemption has been granted; 2. any treatment-emergent condition or exacerbation of underlying condition during original Phase II trial, which in the investigator's opinion would likely compromise the subject's safety or compliance with the study procedures; 3. female or childbearing potential 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 14 days after the end of the trial (or after the last intake of ART);
Note : Hormone-based contraception may not be reliable when taking TMC125, therefore to be eligible for this study woman of childbearing potential should either: (1) use a double barrier method to prevent pregnancy (i.e., using a condom with diaphragm or cervical cap; or (2) use hormone-based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom); or (3) use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom); or (4) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner.
Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy and women who have a tubal ligation are considered of non-childbearing potential.
4. A grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis; 5. Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table; with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions; grade 4 elevation of glucose in subjects with pre-existing diabetes. 6. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR] > 1.5 or albumin < 30 g/l or bilirubin > 2.5 x ULN). |
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E.5 End points |
E.5.1 | Primary end point(s) |
to evaluate the long-term safety and tolerability of TMC125 |
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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 | Yes |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 35 |
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 | 7 |
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 | 7 |