E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV patients with limited to no treatment options |
|
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 |
This program is designed to provide expanded access to MK-0518 prior to the product's
approval and availability on the market. The safety and tolerability of MK-0518 400 mg
b.i.d. for the treatment of HIV-1 infection will be monitored. |
|
E.2.2 | Secondary objectives of the trial |
This program is designed to provide expanded access to MK-0518 prior to the product's
approval and availability on the market. The safety and tolerability of MK-0518 400 mg
b.i.d. for the treatment of HIV-1 infection will be monitored. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
In patients with document HIV-1 infection:
1. Patient is a male or female at least 16 years of age.
2. Patient has limited or no treatment options due to resistance or intolerance to
multiple antiretroviral regimens.
Patient has documented resistance to at least 1 drug in each of the 3
classes of licensed oral ARTs (NNRTI, NRTI, and PI) by genotype or
phenotype testing.
Intolerance is defined as having had a clinically significant adverse event
which in the opinion of the investigator provides a contraindication to the
use of any drug in that class.
3. Patient is not achieving adequate virologic suppression on his/her current regimen
and at risk of clinical or immunologic progression.
4. Patients should be considered clinically stable, in the opinion of the investigator,
at the time of entry into the study; i.e., clinical status and all chronic medications,
except for antiretroviral agents, should be unchanged for at least 2 weeks prior to
the start of treatment in this study.
5. 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. |
|
E.4 | Principal exclusion criteria |
1. Prior or current participation in MK-0518 clinical trial.
Note: Patients who have been receiving MK-0518 via other compassionate
use/emergency use mechanisms, can be enrolled in this study.
2. Patient requires or is anticipated to require any of the prohibited medications
noted in the protocol.
3. Patients with acute hepatitis due to any cause or clinically significant chronic liver
disease including but not limited to cirrhosis, ascites, encephalopathy,
hypoalbuminemia, prolonged PT/PTT and/or esophageal varices.
4. Patient has severe renal insufficiency defined as a calculated creatinine clearance
at time of Screening <30 mL/min, based on the Cockcroft-Gault equation which is
as follows (and 0.85X this value for females):
Clcr (mL/min) = (140-age) x weight (in kg)
72 x serum creatinine (mg/dL)
5. Patient has a condition (including but not limited to alcohol or other substance
abuse) which in the opinion of the investigator would interfere with patient
compliance or safety.
6. Female patient is pregnant or breast-feeding, or expecting to conceive or donate
eggs during the study. Male patient is planning to impregnate or provide sperm
donation during the study.7. 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.
Note: If local guidelines permit, consent may be obtained from those patients
who are 16 or 17 years of age.
8. Patient has significant hypersensitivity or other contraindication to any of the
components of the study drug. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
as this is an early access program the only endpoint is the adverse experience evaluation |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |