E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of HIV-1 infection |
|
MedDRA Classification |
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 determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between nevirapine (twice daily) and efavirenz. |
|
E.2.2 | Secondary objectives of the trial |
1. To determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between the four treatment arms. 2. To determine whether the percentage of patients with virological failure after 144 weeks of follow-up is different between the four treatment arms. 3. To determine whether the percentage of patients with pVL<50 copies/mL or who experienced CDC-C event or died at week 144 is different between the four treament arms. 4. To determine whether the change in CD4 cells and plasma lipids between the start of treatment and week 144 is different between the four treament arms. 5. To determine whether the prevalence of clinical and laboratory AEs at the cross-sectonal evaluation is different between the four treatment arms. 6. To determine which human genes are associated with nevirapine pharmacokinetics and adverse events associated with nevirapine use. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Participation in the initial 2NN study (protocol 1100.1288) 2. Under active follow-up at the end of the initial 2NN study (i.e. at week 48), whether or not using randomized treatment. 3. Ability and willingness to give written informed consent. |
|
E.4 | Principal exclusion criteria |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is treatment failure - a composite endpoint based on virology, disease progression and use of study medication. It is defined as the first occurrence of either of the following: (1) less than 1 log 10 decline in pVL measurements within the first 12 weeks, two consecutive pVL measurements > or equal to 50 copies/mL from week 24 onwards, or a pVL > or equal to 50 copies/mL at week 144; (2) CDC-C event from 8 weeks onwards or death; (3) change of allocated treatment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | 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.8.5 | 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 | 0 |
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 | 0 |