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 | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020192 |
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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 |
Primary objective is to compare: In antiretroviral-naïve patients the antiviral activity of a lopinavir/ritonavir (LPV/r)-single drug regimen versus a HAART standard triple regimen of lopinavir/ritonavir in combination with zidovudine (AZT) and lamivudine (3TC). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare between the two arms: 1) CD4 evolution 2) In failing patients: occurrence of mutation in the HIV protease and RT 3) Occurrence of AIDS clinical events 4) Safety of NRTI-sparing versus a PI with 2 NRTIs regimen: clinical and biological tolerance i.e. mitochondrial toxicity, metabolic toxicity, fat redistribution with DEXA scan. 5) Patient’s adherence and QOL |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/ Independent Ethic Committee (IEC)+, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed. 2.Subject is at least 18 years of age. 3.If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one barrier method of birth control. 4.If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative. 5.Subject is not breast-feeding. 6.Subject is naïve to antiretroviral treatment with reverse transcriptase inhibitor or protease inhibitor. 7.Subject has a plasma HIV RNA level < 100 000 copies/mL at screening. 8.Subject has a CD4 cell count > 100 cells/mm3 at screening. 9.Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. 10.Subject has a Karnofsky Score greater than or equal to 70. 11.Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would adversely affect his/her participating in this study. 12.Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and metheylergonovine), rifampin, lovastatin, simvastatin, and St. John’s wort. 13.Subject agrees not to take any medication during the study, including over the counter medicine, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator. 14.Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott.
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E.4 | Principal exclusion criteria |
1.Subject with an HIV primo-infection status. 2.Presence of the following mutation: In the protease: one among 32, 47, 48, 50, 82, 84, 90 OR more than 3 mutations from the LPV mutation score 10, 20, 24, 46, 53, 54, 63, 71 In the reverse transcriptase: 215 or 184. 3.Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse. 4.Subject has a history of psychiatric illness. 5.Screening laboratory analyses show any of the following abnormal laboratory results: Hemoglobin ≤ 8.0 g/dL, Absolute neutrophil count ≤ 750 cells/µL, Platelet count ≤ 50,000 per mL, ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN), Creatinine ≥ 1.5 x Upper Limit of Normal (ULN), 6.Subject has received any investigational drug within 30 days prior to study drug administration. 7.For any reason, subject is considered by the investigator to be an unsuitable candidate for the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportions of subjects with virologic response defined as having plasma HIV-1 RNA below 400 copies/mL at Week 24 AND below 50 copies/mL at Week 48 and Week 96. |
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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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Last visit of the last subject |
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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 | 2 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |