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 | 9.1 |
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 |
1) To evaluate the change in total cholesterol, triglycerides, non-HDL-C, and LDL-C associated with the use of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the mean percent change from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 12. 2) To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by proportion of patients with viral load <50 copies/mL at Week 24. 3) To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as assessed by review of the accumulated safety data at Week 24. |
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E.2.2 | Secondary objectives of the trial |
1) To evaluate the change in total cholesterol, triglycerides, non-HDL-C, and LDL-C associated with the use of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the mean percent change from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 24 and 48. 2) To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the proportion of patients with viral load <50 copies/mL at Week 48 and the change from baseline in CD4 cell counts at Week 24 and Week 48. 3) To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as assessed by review of the accumulated safety data at Week 48. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patient is a male or female at least 18 years of age on the day of signing the informed consent. 2) Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV PCR. 3) Patient has documented HIV RNA <50 copies/mL for at least 3 months prior to study entry while on a KALETRA (dosed as 400 mg lopinavir/100 mg ritonavir twice daily) based regimen without a change in antiretroviral therapy and with no documentation of HIV RNA ≥50 copies/mL during this time. 4) Patient has no history of coronary artery disease. 5) Patient has the following laboratory values within 35 days prior to the treatment phase of this study: a. Alkaline phosphatase ≤ 5.0 x upper limit of normal b. AST (SGOT) and ALT (SGPT) ≤ 5.0 x upper limit of normal.
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E.4 | Principal exclusion criteria |
1) Patient is receiving a KALETRA based regimen that includes Stavudine (d4T) as a component of the background antiretroviral therapy. 2) Patient is receiving a KALETRA based regimen that includes a second protease inhibitor in addition to KALETRA. 3) Patient is currently receiving, or has received in the past twelve weeks, agents known to have an effect on lipid levels (for example: fish oils, lipidol, bile-acid sequestrants, HMG-CoA reductase inhibitors [such as simvastatin, atorvastatin, rosuvastatin], ezetimibe, ezetimibe/simvastatin, fibrates, niacin, plant sterols, and/or red yeast). 4) Patient has a medical history which includes diabetes mellitus.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy - proportion of patients with plasma HIV RNA < 50 copies/mL at Week 24. Safety - mean percent changes from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 12.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
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 | 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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |