MedTrace Logo

Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

NCT00571961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-11-21

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

Kaletra (lopinavir/ritonavir)

4 tablets, once a day (800 mg/dose) on Days 2 through 14 of this study

DRUG

buprenorphine

Buprenorphine will be obtained through prescription at the subject's drug treatment program.

OTHER

Clinical evaluations/Blood draws

Physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (blood chemistry and blood counts), PK blood draws.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Robert D Bruce, MD · Yale University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571961 on ClinicalTrials.gov