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Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Drug: lopinavir/ritonavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
Study Start Date : November 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Drug: lopinavir/ritonavir
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Other Names:
  • ABT-378
  • Kaletra
Active Comparator: 2 Drug: lopinavir/ritonavir
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Other Names:
  • ABT-378
  • Kaletra


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ]
  2. CD4 [ Time Frame: Baseline, Week 24 and Week 48 ]

Secondary Outcome Measures :
  1. Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00648999


Locations
Mexico
Site Ref # / Investigator 4049
Mexico City, Distrito Federal, Mexico, 01030
Site Ref # / Investigator 4050
Mexico City, Distrito Federal, Mexico, 01120
Site Ref # / Investigator 4051
Mexico City, Distrito Federal, Mexico, 09220
Site Ref # / Investigator 4077
Mexico City, Distrito Federal, Mexico, 10300
Site Ref # / Investigator 4056
Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4074
Leon, Guanajauto, Mexico
Site Ref # / Investigator 4054
Morelia, Michoacan, Mexico
Site Ref # / Investigator 4072
Tepic, Nayarit, Mexico
Site Ref # / Investigator 4055
Culiacan, Sinaloa, Mexico
Site Ref # / Investigator 4075
Merida, Yucatan, Mexico, 97219
Site Ref # / Investigator 4073
Chihuahua, Mexico, 31310
Site Ref # / Investigator 4052
Oaxaca, Mexico
Site Ref # / Investigator 4053
Puebla, Mexico, 72570
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jose Canadas, MD AbbVie
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00648999     History of Changes
Other Study ID Numbers: MEXI-P01-02
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Kaletra

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
 Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors