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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
May 31, 2002
June 3, 2002
April 1, 2008
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 NCT00038532 on ClinicalTrials.gov Archive Site
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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
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
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.
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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: Amprenavir/ritonavir
  • Drug: Saquinavir/ritonavir
  • Drug: Efavirenz
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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
24
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   France,   Germany,   Italy,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
 
 
NCT00038532
M01-287
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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