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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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038636
First received: June 3, 2002
Last updated: August 13, 2006
Last verified: August 2006

June 3, 2002
August 13, 2006
September 2000
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Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
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Complete list of historical versions of study NCT00038636 on ClinicalTrials.gov Archive Site
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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
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/ritonavir
  • Drug: Ritonavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Spain
 
NCT00038636
M99-049
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Abbott
Not Provided
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Dept.
Abbott
August 2006

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