Buprenorphine/Raltegravir Pharmacokinetic Interaction Study

NCT00858962 | Completed Results

• 2 other identifiers: 0811004456R01DA025932
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection; HIV Infections

Keywords

HIV; Pharmacokinetics; Pharmacodynamics; Buprenorphine; Raltegravir; HIV seronegativity; Interaction

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)

  PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.

  6-14 days after beginning co-administration of drugs

Study Arms (1)

Bup/Ral

EXPERIMENTAL

Buprenorphine and Raltegravir co-administration

Drug: Raltegravir

Interventions

Raltegravir DRUG

400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days.

Also known as: Isentress

Bup/Ral

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The sample size was small, though within the range of similar drug-drug interaction studies. This study utilized a within-subject design with patients acting as their own controls (thereby resulting in less intra-patient variability).

Results Point of Contact

• Title: R. Douglas Bruce, MD, MA
• Organization: Yale University AIDS Program

robert.bruce@yale.edu

(203) 737-6133

Study Officials

• Robert D Bruce, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 10, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 21, 2012
• Results First Posted: November 21, 2012

Record last verified: 2012-10

Locations

US (1)