Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

March 14, 2013 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Chihuahua, Mexico, 31310
        • Site Ref # / Investigator 4073
      • Oaxaca, Mexico
        • Site Ref # / Investigator 4052
      • Puebla, Mexico, 72570
        • Site Ref # / Investigator 4053
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 01030
        • Site Ref # / Investigator 4049
      • Mexico City, Distrito Federal, Mexico, 01120
        • Site Ref # / Investigator 4050
      • Mexico City, Distrito Federal, Mexico, 09220
        • Site Ref # / Investigator 4051
      • Mexico City, Distrito Federal, Mexico, 10300
        • Site Ref # / Investigator 4077
      • Mexico City, Distrito Federal, Mexico
        • Site Ref # / Investigator 4056
    • Guanajauto
      • Leon, Guanajauto, Mexico
        • Site Ref # / Investigator 4074
    • Michoacan
      • Morelia, Michoacan, Mexico
        • Site Ref # / Investigator 4054
    • Nayarit
      • Tepic, Nayarit, Mexico
        • Site Ref # / Investigator 4072
    • Sinaloa
      • Culiacan, Sinaloa, Mexico
        • Site Ref # / Investigator 4055
    • Yucatan
      • Merida, Yucatan, Mexico, 97219
        • Site Ref # / Investigator 4075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: Baseline, Week 4, Week 24 and Week 48
Baseline, Week 4, Week 24 and Week 48
CD4
Time Frame: Baseline, Week 24 and Week 48
Baseline, Week 24 and Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Event Monitoring
Time Frame: Baseline, Week 4, Week 24 and Week 48
Baseline, Week 4, Week 24 and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Jose Canadas, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEXI-P01-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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