Buprenorphine/Raltegravir Pharmacokinetic Interaction Study

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this protocol is to study the effect of an HIV medication known as Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine for at least 3 weeks before study entry. This will be determined by giving Raltegravir along with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood. The investigators will also learn about the effects of Buprenorphine on Raltegravir and about the safety of taking these two medications together.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: Merck Sharp & Dohme Corp.; National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Raltegravir Potassium

Criteria

Inclusion Criteria:

• Patients who are opioid dependent on long-term buprenorphine/naloxone (BUP/NLX) maintenance (minimum of 4 weeks) and who must remain at a stable dose of buprenorphine for at least 3 weeks deemed by the investigator to have acceptable medical history, physical examination and clinical laboratory evaluations consistent with BUP maintenance will be eligible to participate in the study.

• Body weight >60 kg for males and >40 kg for females

• Male or females, ages > 21 to < 60 years.

• Women of childbearing potential (WOCBP) must not be nursing or pregnant and must be 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.

Exclusion Criteria:

• 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.

• Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of enrollment and throughout the study.

• Women who are currently pregnant or breastfeeding.

• 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.

• Proven or suspected acute hepatitis at the time of study entry

• Any major surgery within 4 weeks of enrollment. Minor surgical procedures requiring local anesthesia are exceptions.

• 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-residence period

• Evidence of organ dysfunction or any clinically relevant (as determined by the investigator) deviations from the norms observed in a buprenorphine/naloxone treated population in physical examination, vital signs, or clinical laboratory determinations.

• Positive breathalyzer alcohol test, or positive urine screen for barbiturates, benzodiazepines, amphetamines, cocaine or opioids other than buprenorphine/naloxone.

• Subjects with AST, ALT or bilirubin > 3.0X the upper limit of normal

• Hemoglobin < 9 g/dL, and platelet count < 75,000/mm3.

• Positive serum or urine for HCG.

• History of any significant drug allergy, drug rash or sensitivity to any class of drugs relevant to the study drugs.

• HIV antibody positive

• Exposure to any investigational drug within 4 weeks of enrollment and throughout the study.

• Prior exposure to Raltegravir.

• Use of any agent (prescribed or otherwise) within 2 weeks of dosing, that is known or suspected to induce or inhibit drug metabolizing enzymes (e.g., cimetidine and compounds in the barbiturate and phenothiazine classes), affect renal tubular secretion (e.g., probenecid, beta-lactam antibiotics), gastrointestinal motility (e.g., metoclopramide, propantheline, loperamide, or narcotic analgesics or opioids other than buprenorphine/naloxone), or uric acid metabolism (e.g., allopurinol) or gastrointestinal pH (including antacids, H2-receptor antagonists, proton pump inhibitors etc.).

• Use of over-the-counter medications and herbal preparations, within 1 week prior to enrollment and throughout the study.

• Use of St. John's Wort (Hypericum) within four weeks prior to study enrollment and throughout the study.

• Consumption of grapefruit or grapefruit juice within 1 week of study entry and throughout the study.