| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 6.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10000807 |
|
| 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 b.i.d. compared with KALETRA 400/100 b.i.d., each in combination with background antiretroviral therapy, as measured by the mean percent change from baseline of such paramenters at week 12.
2)To evaluate the antiretroviral activity of MK-0518 400 b.i.d. compared with KALETRA 400/100 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. |
|
| 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 comination wiht background antiretroviral therapy, as measured by the mean percent change from baseline of such parameters at week 24.2)To evaluate the antiretroviral activity of MK-0518 400 b.i.d. compared with KALETRA 400/100 b.i.d., each in combination with background antiretroviral therapy, as measured by proportion of patients with viral load <50 copies mL at week 48. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
. 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. Patients with chronic Hepatitis B and/or C coinfection may be enrolled provided the patients are stable and meet all eligibility criteria.
Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results.
6. Patient has no clinical evidence of active pulmonary disease; at investigator discretion a chest x-ray could be obtained if felt necessary.
7. Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence. Oral contraceptives are not recommended for this study because contraceptive steroid concentrations may be altered when KALETRA is co-administered with oral contraceptives or with the contraceptive patch.OR
Patient who is not of reproductive potential ; is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception.
8. Patient agrees to remain off prohibited concomitant medications as outlined in Section 3.2.1 of the protocol. |
|
| 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.
5. Patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patientﾒs participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
6. Patient has a history of alcohol or other substance abuse which in the opinion of the investigator would interfere with patient compliance or safety.
7. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
8. Patient has ever used any experimental HIV-integrase inhibitor.
9. Patient has used systemic immunosuppressive therapy (e.g., 20 mg or more of prednisone or equivalent per day) within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
10. Patient requires hemodialysis.
11. Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs.
12. Patient has chronic hepatitis, including chronic hepatitis B and/or C, with unstable liver function tests. This includes patients who, in the opinion of the investigator, have evidence of impairment of hepatic synthetic function, such as hypoalbuminemia or prolonged PT and PTT.
13. Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1) Mean percent change from baseline of total cholesterol, triglycerides, non-HDL-C and LDL-c
2)proportion of patients with viral load <50 copies/mL |
|
| 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 | 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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) | Information not present in EudraCT |
| 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 | 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 |
|
| 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
| |
| 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 | 11 |
| 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 | 11 |
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