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Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038532
First Posted: June 3, 2002
Last Update Posted: April 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

Condition Intervention Phase
HIV Infections Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir Drug: Efavirenz Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48

Estimated Enrollment: 24
Study Start Date: April 2001
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion:

  • Remain on present anti-HIV drugs during screening until a new regimen is started.
  • Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
  • Have an HIV which shows reduced susceptibility to lopinavir.
  • Are at least 18 years old.
  • Are not presently ill.
  • Have not been treated for an opportunistic infection within 30 days of screening.
  • Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
  • Agree to use an accepted barrier method of birth control.

Exclusion:

  • Female subject is pregnant or lactating.
  • Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
  • Are taking chemotherapy.
  • Have a medical problem with their pancreas.
  • Have been screened for this study within the past 12 weeks.
  • Appear to be unsuitable in the opinion of the doctor.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038532


  Show 54 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Development
  More Information

ClinicalTrials.gov Identifier: NCT00038532     History of Changes
Obsolete Identifiers: NCT00021619
Other Study ID Numbers: M01-287
First Submitted: May 31, 2002
First Posted: June 3, 2002
Last Update Posted: April 1, 2008
Last Verified: July 2006

Keywords provided by Abbott:
treatment experienced
HIV

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
Ritonavir
HIV Protease Inhibitors
Saquinavir
Amprenavir
Lopinavir
Efavirenz
Protease 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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers