Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	March 28, 2008
Last Updated Date	March 31, 2008
Start Date ^ICMJE	November 2003
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 31, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00648999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 31, 2008)	Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Official Title ^ICMJE	Phase IV Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
Brief Summary	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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Parallel Assignment
Condition ^ICMJE	HIV Infections Kaletra
Intervention ^ICMJE	Drug: lopinavir/ritonavir Drug: lopinavir /ritonavir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	207
Completion Date
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Mexico

Administrative Information
NCT ID ^ICMJE	NCT00648999
Responsible Party	Max Saráchaga / Medical Director, Abbott
Study ID Numbers ^ICMJE	MEXI-P01-02
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP