E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unspecified human immuno-deficiency virus [HIV] disease |
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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 | 10020162 |
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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 |
Main objective : In HIV-infected patients failing therapy, with HIV RNA >1000 copies/mL and documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretrovirals (ARTs) (Nucleoside Reverse Transcriptase Inhibitors [NRTIs], Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs], and Protease Inhibitors [PIs]): (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with Optimized Background Therapy (OBT), as measured by proportion of patients achieving HIV RNA <400 copies/mL at Week 24. (2) Evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, assessed by review of the accumulated safety data.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives : : In HIV-infected patients failing therapy, with HIV RNA >1000 copies/mL and documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretrovirals (ARTs) (Nucleoside Reverse Transcriptase Inhibitors [NRTIs], Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs], and Protease Inhibitors [PIs]) 1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, as measured by the following parameters at Week 24: (a) Proportion of patients with virologic response at week 24; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. in combination with OBT at Week 48.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a. Patient is a male or female at least 16 years of age. b. Patient has screening plasma HIV RNA (determined by the central laboratory) >1000 copies/mL within 60 days prior to the treatment phase of this study. c. Patient is ART experienced and on stable ART for ≥2 months. d. Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report from the central laboratory used for this protocol. In cases where the central laboratory resistance sample fails or results are not consistent with prior resistance history, patients may be allowed to enroll based on prior resistance results and ART regimen history, after discussion with the Merck Medical Monitor.
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E.4 | Principal exclusion criteria |
a. Patient has used another experimental HIV-integrase inhibitor. b. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. c. Patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic hepatitis other than stable chronic Hepatitis B and/or C. d. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient. e. Inability to obtain signed informed consent from a patient age 18 or older, or when a parent/legal representative has provided consent, the inability to obtain assent from a patient 16 or 17 years of age.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety, tolerability, and proportion of patients achieving HIV RNA <400 copies/mL at Week 24 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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) | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
This is a double blind study but patients who experience protocol specifed virologic failure have an |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 |
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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 | 6 |
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 | 6 |