E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of HIV infection in antiretrovival-experienced HIV-1 infected subjects |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | 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 |
To compare the safety, tolerability and antiviral activity of QD and BID dosing of the lopinavir/ritonavir tablet formulation in subjects with detectable viral load while receiving their current antiretroviral therapy. |
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E.2.2 | Secondary objectives of the trial |
To characterize the development of resistance in QD and BID dosing of the lopinavir/ritonavir tablet in antiretroviral-experienced subjects. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subject is at least 18 years of age. 2. Subject has voluntarily signed and dated an informed consent form 3. Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 weeks. 4. Subject has never received lopinavir/ritonavir. 5. Subject is currently failing his/her antiretroviral regimen with the most recent two consecutive pre-study plasma HIV-1 RNA levels 400 copies/mL with the most recent being 1000 copies/mL, and in the investigator s opinion, should change therapy. 6. Subject has plasma HIV-1 RNA levels 1000 copies/mL at Screening. 7. Based on HIV-1 drug resistance genotypic test results at the Screening Visit and prior treatment history, the investigator considers lopinavir/ritonavir plus at least two NRTIs to be an appropriate treatment for the subject. 8. Subject does not require and agrees not to take any antiretroviral medication except lopinavir/ritonavir and NRTIs |
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E.4 | Principal exclusion criteria |
1. Pregnancy / Breast feeding 2. Screening laboratory analyses show any of the following abnormal laboratory results 9679; Hemoglobin 8.0 g/dL 9679; Absolute neutrophil count 750 cells/mL 9679; Platelet count 50,000 mm3 9679; ALT SGOT or AST SGPT 5.0 Upper Limit of Normal ULN 3. Subject has a history of an allergic reaction or significant sensitivity to lopinavir or ritonavir. 4. Subject has an ongoing history of substance abuse recreational drugs, alcohol or psychiatric illness that could preclude adherence with the protocol. 5. Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic or hepatic disease that would adversely affect his/her participating in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy analysis will be the proportion of subjects responding i.e., not demonstrating virologic failure at Week 48, based on the FDA Time to Loss of Virologic Response TLOVR algorithm. The estimate of the proportion of subjects responding will be provided for each treatment group, along with the corresponding 95 confidence interval for the difference in proportions QD group minus BID group , based on the normal approximation to the binomial distribution. If the lower limit of the confidence interval is at or above 12 , the QD group will be considered non-inferior to the BID group. Differences between randomized treatment groups will be assessed using Fisher s exact test. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Stesso farmaco ad altro schema di assunzione |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |