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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.
Information provided by:
Abbott Identifier:
First received: June 3, 2002
Last updated: August 13, 2006
Last verified: August 2006
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir

Condition Intervention Phase
HIV Infections
Drug: Lopinavir/ritonavir
Drug: Ritonavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts

Estimated Enrollment: 36
Study Start Date: September 2000

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00038636

United States, California
UCSD Treatment Center
San Diego, California, United States, 92103-6329
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Hopital Pitie-Salpetriere
Paris, France, 75651
Hospital Europeen Georges Pompidou
Paris, France, 75908
Hospital Clinico de Barcelona
Barcelona, Spain, 08036
Ciutat Sanitaria de Bellvitge
Barcelona, Spain, 08907
Sponsors and Collaborators
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Dept.
  More Information Identifier: NCT00038636     History of Changes
Obsolete Identifiers: NCT00006210
Other Study ID Numbers: M99-049
Study First Received: June 3, 2002
Last Updated: August 13, 2006

Keywords provided by Abbott:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2017