The pharmacokinetics of once daily Kaletra and methadone in a population of HIV positiive drug users.

• Conditions: HIV-1 Positive Injection Drug Users; MedDRA version: 12.0Level: LLTClassification code 10020180Term: HIV positive

• Registration Number: EUCTR2009-015647-16-IE
• Lead Sponsor: GUIDE Clinic, St James's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-09
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 ß-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified