E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects experiencing virologic failure after a HAART regimen containing ATV |
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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 |
To compare the prevalence of the I50L substitution in viral isolates from subjects virologically failing ATV-containing HAART regimens with the I50L substitution prevalence in subjects failing ATV/r-containing HAART regimens, regardless of prior treatment history. |
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E.2.2 | Secondary objectives of the trial |
- To determine the overall prevalence of the I50L substitution in subjects failing ATV-containing HAART regimens. - To compare the prevalence of the I50L substitution in subjects failing ATV/r as a first PI-containing regimen versus subjects failing ATV/r as a second or later PI-containing regimen. - To compare the prevalence of the I50L substitution in subjects failing ATV as a first PI-containing regimen versus subjects failing ATV as a second or later PI-containing regimen. - To compare the prevalence of the I50L substitution (regardless of ritonavir combination) in subjects failing ATV as a first PI-containing regimen versus subjects failing ATV as a second or later PI-containing regimen. - To describe patterns of amino acid substitutions in subjects failing on ATV compared with ATV/r. - To determine if the I50L substitution is associated with: 1) other specific protease substitutions, 2) NRTI substitutions. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Subject must be able to understand the informed consent and to provide written informed consent; - Subjects currently on an antiretroviral regimen containing ATV with either: 1) a confirmed virologic rebound (an HIV RNA ≥ 1000 copies/mL, after achieving a value < 400 copies/mL on at least two consecutive measurements) or 2) an HIV RNA ≥ 1000 copies/mL after 24 weeks of therapy. In both cases, HIV RNA ≥ 1000 copies/mL must be confirmed by screening/enrollment measurement within 14-90 days of the first HIV RNA value. The subject must be on the ATV-containing HAART regimen at the time of enrollment. The confirming viral load at screening/enrollment must be plasma HIV-1 RNA level obtained by using the Roche Amplicor Ultrasensitive Assay (Version 1.5) (or other approved assay as agreed upon by the medical monitor). - Men and women ≥ 18 years of age. |
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E.4 | Principal exclusion criteria |
- VL <1000 c/mL at the screening visit. - Individuals exhibiting virologic failure on a HAART regimen that does not include ATV. - Subjects who are incapable to give informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The prevalence of the I50L substitution in viral isolates from subjects virologically failing ATV-containing HAART regimens with the I50L substitution prevalence in subjects failing ATV/r-containing HAART regimens, regardless of prior treatment history. |
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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 | No |
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 |
Prevalence of the I50L substitution |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 |
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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
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All procedures for this study are completed in one study visit.
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |