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.

First Received: June 3, 2002 Last Updated: August 13, 2006 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00038636

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038636

Locations

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
France
Hopital Pitie-Salpetriere
Paris, France, 75651
Hopital Pitie-Salpetriere
Paris, France, 75651
Hospital Europeen Georges Pompidou
Paris, France, 75908
Spain
Hospital Clinico de Barcelona
Barcelona, Spain, 08036
Ciutat Sanitaria de Bellvitge
Barcelona, Spain, 08907

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Eugene Sun, M.D.

Divisional Vice President, Infectious Diseases and Virology Dept.

More Information

No publications provided

Study ID Numbers:	M99-049
Study First Received:	June 3, 2002
Last Updated:	August 13, 2006
ClinicalTrials.gov Identifier:	NCT00038636 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

HIV

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents

Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 09, 2009