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

August 13, 2006 updated by: Abbott
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75651
        • Hôpital Pitié-Salpêtrière
      • Paris, France, 75908
        • Hospital Europeen Georges Pompidou
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínico de Barcelona
      • Barcelona, Spain, 08907
        • Ciutat Sanitaria de Bellvitge
  • United States
    • California
      • San Diego, California, United States, 92103-6329
        • UCSD Treatment Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Chair: Eugene Sun, M.D., Divisional Vice President, Infectious Diseases and Virology Dept.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Registration Dates

First Submitted

June 3, 2002

First Submitted That Met QC Criteria

June 3, 2002

First Posted (Estimate)

June 4, 2002

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 13, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M99-049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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