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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	February 19, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00004580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
Official Title ^ICMJE	Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
Brief Summary	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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Lopinavir/Ritonavir Drug: Nevirapine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00004580
Responsible Party
Study ID Numbers ^ICMJE	285B, M97-765
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP