E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of HIV-1 infection in combination with other agents in antiretroviral treatment naive and antiretroviral treatment-experienced subjects. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 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 |
To assess the long-term safety and efficacy of lersivirine in subjects who have completed treatment with lersivirine in the parent protocols. |
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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 must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Completion of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols. 3. HIV-1 RNA level <50 copies/mL at Week 84 of the parent protocol(if the HIV-1 RNA level is ≥50 copies/mL at Week 84, a second HIV-1 RNA level must be performed and confirmed to be <50 copies/mL prior to the Week 96 visit of the parent protocol). 4. Considered by the investigator to be an appropriate candidate for continued treatment with lersivirine (or comparator, where required by local regulation) plus the background therapy defined in the parent protocol. 5. Negative urine pregnancy test for Women of Child Bearing Potential (WOCBP) at the Day 1 visit, prior to receiving study medication. See Section 4.3. 6. Use of effective double barrier contraception for WOCBP for the duration of the study and for 28 days after leaving the study. For WOCBP treated with efavirenz, this period should be for the duration of the study and for 12 weeks after leaving the study. Use of effective barrier contraception for males for the duration of the study. See Section 4.3. 7. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. |
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the study: 1. Presence of any Grade 4 Division of AIDS (DAIDS) toxicity (except for lipids and asymptomatic glucose elevations and those discussed and agreed by the investigator and the Sponsor’s Medical Monitor prior to enrollment). 2. Use of prohibited concomitant medications, as defined in Section 5.5, Concomitant Medications. 3. Concurrent treatment with another investigational product or in another clinical trial, except the lersivirine parent protocols. 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or in the judgment of the investigator, would make the subject inappropriate for entry into this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
> Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests. > The percentage of subjects with HIV-1 RNA level <50 copies/mL at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol). |
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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 | 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 | Yes |
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) | Yes |
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 | 12 |
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 | 5 |
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 | 5 |
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 |