A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors - Tabular View

Tracking Information

First Received Date ^ICMJE

June 3, 2002

Last Updated Date

August 13, 2006

Start Date ^ICMJE

September 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts

Original Primary Outcome Measures ^ICMJE

Virologic and immunoligic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts

Change History

Complete list of historical versions of study NCT00038636 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors

Official Title ^ICMJE

A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors

Brief Summary

The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Lopinavir/ritonavir
Drug: Ritonavir

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:

HIV positive
Are at least 18 years old
Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
HIV RNA level > 1000 copies/mL
Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor

Exclusion:

Subject is pregnant or breast-feeding
Subject has received an investigational drug within 30 days prior to screening
Have a history of pancreatitis
History of intolerance to ritonavir
Abnormal laboratory tests at screening

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Spain

Administrative Information

NCT ID ^ICMJE

NCT00038636

Responsible Party

Study ID Numbers ^ICMJE

M99-049

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Eugene Sun, M.D.

Divisional Vice President, Infectious Diseases and Virology Dept.

Information Provided By

Abbott

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP