Back to resultsA Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lopinavir/ritonavir
Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV
Eligibility Criteria
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
Sites / Locations
- UCSD Treatment Center
- Johns Hopkins Hospital
- The University of North Carolina at Chapel Hill
- Hopital Pitie-Salpetriere
- Hospital Europeen Georges Pompidou
- Hospital Clinico de Barcelona
- Ciutat Sanitaria de Bellvitge
Outcomes
Primary Outcome Measures
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00038636
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Primary Outcome Measure Information:
Title
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Sun, M.D.
Organizational Affiliation
Divisional Vice President, Infectious Diseases and Virology Dept.
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD Treatment Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6329
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hospital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hospital Clinico de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Ciutat Sanitaria de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
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
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