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Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: March 28, 2008
Last updated: March 14, 2013
Last verified: January 2013
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 Intervention Phase
Human Immunodeficiency Virus
Drug: lopinavir/ritonavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: November 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00648999

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)
Study Director: Jose Canadas, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00648999     History of Changes
Other Study ID Numbers: MEXI-P01-02 
Study First Received: March 28, 2008
Last Updated: March 14, 2013
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by AbbVie:

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
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 processed this record on October 28, 2016