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

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

Tracking Information
First Submitted Date  ICMJE May 31, 2002
First Posted Date  ICMJE June 3, 2002
Last Update Posted Date July 28, 2006
Study Start Date  ICMJE April 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2006)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Amprenavir/ritonavir
  • Drug: Saquinavir/ritonavir
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
16
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   France,   Italy,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00038519
Other Study ID Numbers  ICMJE M00-261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Development
PRS Account Abbott
Verification Date July 2006

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