Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-09-30

Brief Summary

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The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

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Detailed Description

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Thirty patients with HIV infection will be enrolled in this open-label, parallel arm pharmacokinetic study. Subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. The safety of these agents in combination will also be explored.

Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.

Group Type EXPERIMENTAL

lopinavir/ritonavir

Intervention Type DRUG

Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.

Arm B

Subjects on lopinavir/ritonavir will add atazanavir.

Group Type EXPERIMENTAL

atazanavir

Intervention Type DRUG

Atazanavir 300 mg daily on Days 6-12.

Interventions

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atazanavir

Atazanavir 300 mg daily on Days 6-12.

Intervention Type DRUG

lopinavir/ritonavir

Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.

Intervention Type DRUG

Other Intervention Names

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Reyataz 300 mg capsules Kaletra 200 mg/50 mg tablets

Eligibility Criteria

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Inclusion Criteria

* HIV-seropositive
* Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
* If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study

Exclusion Criteria

* HIV-1 RNA \> 400 copies/mL if currently receiving antiretroviral therapy
* Concurrent use of CYP450 inhibitors or inducers
* Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
* Concurrent use of medications known to interact with ritonavir or atazanavir
* Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
* Presence of conduction abnormalities on electrocardiogram
* Women who are pregnant or breastfeeding
* Laboratory Abnormalities at baseline:

* Aminotransferases \> 3x ULN
* Serum bilirubin \> 5x ULN
* Serum creatinine \> 1.5x ULN
* Hemoglobin concentration \< 8.0 g/dL
* Absolute neutrophil count \< 800 cells/μL
* Platelet count \< 50,000 cells/μL

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No