HIV-1 Positive Injection Drug Users MedDRA version: 12.0 Level: LLT Classification code 10020180 Term: HIV positive
Conditions
Interventions
Trade Name: Kaletra
Product Name: NA
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: lopinavir/ritonavir
CAS Number: 192725-17-0
Current Sponsor code: NA
Other descriptive name: Kale
Sponsors
GUIDE Clinic, St James's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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. | — |
Countries
Ireland
Outcome results
None listed