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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038532
First received: May 31, 2002
Last updated: March 29, 2008
Last verified: July 2006

May 31, 2002
March 29, 2008
April 2001
Not Provided
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
Not Provided
Complete list of historical versions of study NCT00038532 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
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
  • Drug: Efavirenz
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   France,   Puerto Rico,   Argentina,   Spain,   Brazil,   Canada,   United Kingdom,   Italy,   Poland
 
NCT00038532
M01-287
Not Provided
Not Provided
Abbott
Not Provided
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