Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The main purpose of this protocol is to study the effect of an HIV medication, Kaletra (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving the same dose of buprenorphine for at least 3 weeks. Study Hypothesis: Kaletra (lopinavir/ritonavir) will increase buprenorphine plasma levels without any significant clinical effect on the subject or need for dose adjustment.

Key facts

Study ID

NCT00571961

Run by

Yale University

People needed

12

Starts

2007-01-01

Expected to finish

2008-08-01

Last updated by the study team

2012-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Chronic BUP users enrolled in BUP program, receiving BUP for at least 3 months and on a stable BUP dose for at least 3 weeks.
• Acceptable medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations consistent with BUP maintenance
• Subjects who meet the criteria of opiate dependence, are enrolled in long-term BUP maintenance therapy, and have been on a stable dose of BUP for at least 3 weeks.
• Body weight >60 kg for males and >40 kg for females
• Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2.
• Male or females, ages 18 to 65 years.
• Women of childbearing potential (WOCBP) must not be nursing, pregnant and on adequate non-hormonal contraception to avoid pregnancy. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Study Day 1.

You may not qualify if…

• Sex and Reproductive Status Exceptions
• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks before and after the study.
• WOCBP using a prohibited contraceptive method (oral, injectable, or implantable hormonal agents)
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Medical History and Concurrent Diseases
• History or current evidence of any significant acute or chronic medical illness that, within the investigator's discretion, would interfere with the conduct or interpretation of the study.
• History of nephrolithiasis
• History of acute or chronic pancreatitis.
• History of uncontrolled chronic medical illness which could adversely affect the subject's adherence to study protocol or affect patient safety in the opinion of the investigator
• Use of any medication thought to significantly alter the metabolism of Kaletra, Buprenorphine or naloxone.
• History of any hemolytic disorders (including drug-induced hemolysis).
• Proven or suspected acute hepatitis at the time of study entry.
• Current or recent (within 3 months) gastrointestinal disease which would interfere with the conduct or interpretation of the study.
• Any major surgery within 4 weeks of enrollment. Minor surgical procedures requiring local anesthesia are exceptions.
• Any gastrointestinal surgery that could impact upon the absorption of study drug.
• Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
• Blood transfusion within 4 weeks of enrollment.
• Inability to tolerate oral medication.
• Inability to tolerate venipuncture and/or absence of secure venous access.
• Inability to refrain from smoking during in-patient period
• Known or suspected HIV infection (subjects who are found to be positive upon screen for HIV will be excluded).
• Known active drug or alcohol abuse, which in the opinion of the investigator makes study participation to completion unlikely.
• Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
• Physical and Laboratory Test Findings

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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