CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Kaletra (lopinavir/ritonavir) +2 moredrug
Likely dose
Kaletra (lopinavir/ritonavir) 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00571961
NCT00571961N/ACompleted
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Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

Yale University·interventional·Posted Dec 12, 2007·Updated Nov 21, 2012

In Brief

A clinical study evaluating Kaletra (lopinavir/ritonavir), buprenorphine, and 1 other intervention for HIV Infections. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsAbbott

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartJan 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.6 years ago

Interventions

Kaletra (lopinavir/ritonavir)drug

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

buprenorphinedrug

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

Clinical evaluations/Blood drawsother

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