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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038519
First received: May 31, 2002
Last updated: July 27, 2006
Last verified: July 2006
History of Changes

May 31, 2002
July 27, 2006
April 2001
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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
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Complete list of historical versions of study NCT00038519 on ClinicalTrials.gov Archive Site
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Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
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.

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Amprenavir/ritonavir
  • Drug: Saquinavir/ritonavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   France,   Italy,   Poland,   Puerto Rico,   Spain,   United Kingdom
 
NCT00038519
M00-261
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Abbott
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Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Development
Abbott
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP