E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 Positive Injection Drug Users |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020180 |
E.1.2 | Term | HIV positive |
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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 |
Primary Objective The primary objectives of this study are: 1. to determine the pharmacokinetic interaction between Kaletra, prescribed once daily, and methadone in HIV-1 positive Injection Drug Users. 2. to determine whether these patients experience any methadone withdrawal or overdose symptoms when receiving these two medications.
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E.2.2 | Secondary objectives of the trial |
Secondary Objective The secondary objectives of this study are: 1. to assess the safety and tolerability of Kaletra, prescribed once daily, and methadone in HIV-1 positive Injection Drug Users. 2. to determine trough and peak levels of Kaletra in these patients after 10-14 days of therapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria Only patients who meet all of the following inclusion criteria will be eligible for enrolment into this study: 1. Male or Female patients, > 18 years of age and < 65 years of age, with a documented positive history of HIV-1. 2. Be willing and able to provide written informed consent prior to study participation. 3. Be willing and able to comply with the study treatment and protocol. 4. Be Injection Drug Users on a stable methadone programme and who have been at the same methadone dose for greater than 3 months. 5. Kaletra naive patients starting treatment for first time or treatment experienced patients restarting treatment post > 1 month treatment interruption, where treatment with Kaletra is still considered appropriate according to current resistance test results. 6. Females must have a negative β-HCG test at the screening visit and be practicing a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent) or abstinence, unless surgically sterilized
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E.4 | Principal exclusion criteria |
Patients meeting any of the following exclusion criteria are not eligible for enrolment into this study: 1. Patients with a history of an allergic reaction or significant sensitivity to Kaletra or co-prescribed ART. 2. Patients with a documented resistance to Kaletra. 3. Patients with positive urine toxicology for non-prescribed opiates. 4. Patients who are pregnant or lactating. 5. Patients with significant liver damage of DAIDS grade 4 ALT/AST. 6. Patients taking any other additional drugs (apart from ART) that would interfere with methadone. 7. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements. 8. Any other contraindications, as per the SmPC for Kaletra. 9. Concurrent treatment with an investigational drug or participation in another clinical trial. 10. Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational product
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints of this study are: 1. to evaluate the pharmacokinetic interaction between Kaletra, prescribed once daily, and methadone in HIV-1 positive Injection Drug Users as measured by PK analysis of plasma samples taken at times 0, 1, 2, 4, 6 and 8 hours post methadone dosing prior to, and at the end of, 10-14 days of Kaletra therapy. 2. to evaluate whether these patients experience any methadone withdrawal or overdose symptoms when receiving these two medications by assessing for signs and symptoms of methadone withdrawal/overdose on the Clinical Opiate Withdrawal Scale (COWS) and requirement for methadone dose adjustments.
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.8.1.1 | Randomised | No |
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) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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Subjects’ participation in this study will end following completion of the End of Study Visit (or early withdrawal visit if applicable). Once subjects have completed their participation in this study they will be treated as per routine standard care for this patient population. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |