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Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

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: NCT00648999
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : March 15, 2013
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

March 28, 2008
April 1, 2008
March 15, 2013
November 2003
December 2006   (Final data collection date for primary outcome measure)
  • Quality of Life [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ]
  • CD4 [ Time Frame: Baseline, Week 24 and Week 48 ]
Same as current
Complete list of historical versions of study NCT00648999 on ClinicalTrials.gov Archive Site
Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ]
Same as current
Not Provided
Not Provided
Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.
Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Human Immunodeficiency Virus
Drug: lopinavir/ritonavir
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Other Names:
  • ABT-378
  • Kaletra
  • Active Comparator: 1
    Intervention: Drug: lopinavir/ritonavir
  • Active Comparator: 2
    Intervention: Drug: lopinavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV Infected subjects
  • Subjects failing in current HIV treatment, or
  • Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.

Exclusion Criteria:

  • Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
  • Subject is pregnant
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Jose Canadas, MD AbbVie
January 2013

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