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Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00648999
First received: March 28, 2008
Last updated: March 14, 2013
Last verified: January 2013

March 28, 2008
March 14, 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 ] [ Designated as safety issue: No ]
  • CD4 [ Time Frame: Baseline, Week 24 and Week 48 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.
 
Completed
207
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
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00648999
MEXI-P01-02
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Jose Canadas, MD AbbVie
AbbVie
January 2013

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