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 | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008919 |
E.1.2 | Term | Chronic HIV 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 |
The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of patients with HIV RNA <200 copies/mL 48 weeks after randomisation. |
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E.2.2 | Secondary objectives of the trial |
A number of secondary outcomes will be assessed which are of relevance and interest in the assessment of the performance of the two study treatment regimens. These will include (but will not necessarily be limited to) virological, immunological, safety and antiretroviral treatment change.
In addition some exploratory objectives will also be examined including clinical, metabolic, anthropometric, medication adherence and quality of life.
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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 randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy. The Body Composition Sub Study. Version 1.0 Primary Objective: To determine the difference in mean limb fat changes (absolute and percentage change) as measured by DEXA scan between LPV/r + 2N(t)RTI and LPV/r + raltegravir based ART from baseline to 48 weeks.
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E.3 | Principal inclusion criteria |
1. HIV-1 positive by licensed diagnostic test 2. Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate) 3. Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for ≥ 24 weeks 4. No change in antiretroviral therapy within 12 weeks prior to screening 5. Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (≥7 days apart) HIV RNA results of >500 copies/mL 6. No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors 7. Able to provide written informed consent
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E.4 | Principal exclusion criteria |
1. The following laboratory variables: a) absolute neutrophil count (ANC) <500 cells/L b) hemoglobin <7.0 g/dL c) platelet count <50,000 cells/L d) ALT >5 x ULN 2. Pregnant or nursing mothers 3. Patients with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen 4. Use of immunomodulators within 30 days prior to screening 5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John’s wort) 6. Intercurrent illness requiring hospitalisation 7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator 8. Patients with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study 9. Patients deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the virological efficacy of the two regimens as measured by the proportion of participants with HIV RNA <200 copies/mL 48-weeks and 96 weeks after randomisation in the intention-to-treat (ITT) population. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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.8.4.1 | 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 | 5 |
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 | Yes |
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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The trial will be completed when all patients have attended for 96 weeks of follow-up, unless the DSMB have ceased the study early due to safety or tolerability concerns. |
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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 | 3 |
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 | 3 |