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A Study of ABT-378/Ritonavir ...

A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors

Last Updated: 2009-02-20

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

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Lopinavir/Ritonavir

Intervention Type DRUG

Nevirapine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

\- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.

Patients must have:

\- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.

Prior Medication:

Allowed:

Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
* Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.

Patients with the following prior conditions are excluded:

* Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
* Clinically significant abnormal ECG results.
* Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.

Prior Medication:

Excluded:

* Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing.
* Treatment with a non-nucleoside reverse transcriptase inhibitor.
* Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen.
* Treatment with more than one protease inhibitor concurrently.

Risk Behavior:

Excluded:

* Active substance abuse, alcohol abuse, psychiatric illness.
* Presumption, by investigator, of poor compliance to regimen.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers