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Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor

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ClinicalTrials.gov Identifier: NCT00038519
Recruitment Status : Completed
First Posted : June 3, 2002
Last Update Posted : July 28, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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 or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.
Study Start Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion:

  • Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
  • Subject demonstrates reduced susceptibility to lopinavir.
  • Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
  • The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
  • Subject is at least 18 years of age.
  • Subject has not been treated for an active opportunistic infection within 30 days of screening.

Exclusion:

  • Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
  • Female subject pregnant or lactating.
  • Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
  • Subject is receiving systemic chemotherapy.
  • Subject has a history of acute or chronic pancreatitis.
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): NCT00038519


  Show 52 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: NCT00038519     History of Changes
Other Study ID Numbers: M00-261
First Posted: June 3, 2002    Key Record Dates
Last Update Posted: July 28, 2006
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
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
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents