Clinical Trials

MainTitle

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
Abbott


Information provided by (Responsible Party)
Abbott
ClinicalTrials.gov Identifier
NCT00038636

First received: June 3, 2002
Last updated: August 13, 2006
Last Verified: August 2006
History of Changes
Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Abbott:

Primary Outcome Measures

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

Enrollment: 36
Study Start Date: September 2000

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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 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
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

More Information


Responsible Party: Abbott  
ClinicalTrials.gov Identifier: NCT00038636   History of Changes  
Other Study ID Numbers: M99-049  
Study First Received: June 3, 2002  
Last Updated: August 13, 2006  

Keywords provided by Abbott:

HIV

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.