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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: May 31, 2002
Last updated: July 27, 2006
Last verified: July 2006
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 Intervention Phase
HIV Infections
Drug: Amprenavir/ritonavir
Drug: Saquinavir/ritonavir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

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: 16
Study Start Date: April 2001

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


  • 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.


  • 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
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Please refer to this study by its identifier: NCT00038519

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Sponsors and Collaborators
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Development
  More Information Identifier: NCT00038519     History of Changes
Other Study ID Numbers: M00-261 
Study First Received: May 31, 2002
Last Updated: July 27, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
treatment experienced

Additional relevant MeSH terms:
HIV Protease Inhibitors
Protease Inhibitors
Anti-Bacterial Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antibiotics, Antitubercular
Antitubercular Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 30, 2016