E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Human Immunodeficiency Virus (HIV) Type-1 infection |
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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 | 10020447 |
E.1.2 | Term | Human immunodeficiency virus type I infection with other conditions |
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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 evaluate the lipid benefits of saquinavir tablets (Invirase®) with ritonavir versus lopinavir/ritonavir (Kaletra®) tablets in HIV-1 infected adults switching from Kaletra® soft gel capsules |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of saquinavir tablets with ritonavir versus lopinavir/ritonavir tablets in HIV-1 infected adults switching from Kaletra® soft gel capsules.
To evaluate the additional safety and tolerability (in particular gastro-intestinal adverse events) of saquinavir tablets with ritonavir versus lopinavir/ritonavir tablets in HIV-1 infected adults switching from Kaletra® soft gel capsules
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or non-pregnant, non-nursing females 18 years of age - Seropositive for HIV-1 - On an antiretroviral combination of Kaletra® soft gel capsules with 2 nucleoside/nucleotide analogues for at least 6 months - HIV-1 RNA viral load <50 copies/mL (2 consecutive measurements in the prior 6 months) - No prior protease inhibitor exposure prior to commencing Kaletra® sof gel capsules. - Ability and willingness to provide written informed consent and adhere to the study regimen - Females of childbearing potential must have a documented negative serum or urine pregnancy test at screening/baseline and ensure that 2 reliable forms of contraception are being used, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication.
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E.4 | Principal exclusion criteria |
- Previous treatment with a PI based antiretroviral regimen prior to commencing Kaletra® soft gel capsules - Patients with acute hepatitis B or C infection - Significant renal dysfunction (creatinine clearance [CrCl] <60 mL/min) and/or hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 X ULN and/or documented liver cirrhosis) - Any current known clinical or laboratory parameter of ACTG Grade 4. However, asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate. Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrollment. - Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition such that in the judgment of the investigator the patient would not be able to take or continue a prescribed antiretroviral regimen - Malignancy requiring chemotherapy or radiotherapy - Known hypersensitivity to any of the prescribed antiretroviral drugs or formulation components - Evidence of alcohol and/or drug or substance abuse that in the judgment of the investigator would likely result in the patient being unreliable in fulfilling the conditions of the protocol - History of psychological illness or conditions that in the judgment of the investigator might interfere with the patient’s ability to understand the requirements of the study - History of drug nonadherence that in the judgment of the investigator would result in the patient being unreliable in fulfilling the conditions of this protocol - Patients who had received an investigational new drug within the last 4 weeks - Currently taking, or anticipate taking during the course of the study, any drug contraindicated with the antiretroviral drugs they have been randomized to receive
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is the difference in the change from baseline of fasting LDL cholesterol levels from baseline to week 24 based on an intent-to-treat exposed (ITT/e) analysis. |
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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 | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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 complete when the last patient has their last 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 | 1 |
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 | 1 |