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Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
lopinavir/ritonavir
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Kaletra

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ref # / Investigator 4049
  • Site Ref # / Investigator 4050
  • Site Ref # / Investigator 4051
  • Site Ref # / Investigator 4077
  • Site Ref # / Investigator 4056
  • Site Ref # / Investigator 4074
  • Site Ref # / Investigator 4054
  • Site Ref # / Investigator 4072
  • Site Ref # / Investigator 4055
  • Site Ref # / Investigator 4075
  • Site Ref # / Investigator 4073
  • Site Ref # / Investigator 4052
  • Site Ref # / Investigator 4053

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Quality of Life
CD4

Secondary Outcome Measures

Adverse Event Monitoring

Full Information

First Posted
March 28, 2008
Last Updated
March 14, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00648999
Brief Title
Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Official Title
Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Kaletra

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir
Other Intervention Name(s)
ABT-378, Kaletra
Intervention Description
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
Baseline, Week 4, Week 24 and Week 48
Title
CD4
Time Frame
Baseline, Week 24 and Week 48
Secondary Outcome Measure Information:
Title
Adverse Event Monitoring
Time Frame
Baseline, Week 4, Week 24 and Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Canadas, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 4049
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
01030
Country
Mexico
Facility Name
Site Ref # / Investigator 4050
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Site Ref # / Investigator 4051
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
09220
Country
Mexico
Facility Name
Site Ref # / Investigator 4077
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
10300
Country
Mexico
Facility Name
Site Ref # / Investigator 4056
City
Mexico City
State/Province
Distrito Federal
Country
Mexico
Facility Name
Site Ref # / Investigator 4074
City
Leon
State/Province
Guanajauto
Country
Mexico
Facility Name
Site Ref # / Investigator 4054
City
Morelia
State/Province
Michoacan
Country
Mexico
Facility Name
Site Ref # / Investigator 4072
City
Tepic
State/Province
Nayarit
Country
Mexico
Facility Name
Site Ref # / Investigator 4055
City
Culiacan
State/Province
Sinaloa
Country
Mexico
Facility Name
Site Ref # / Investigator 4075
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97219
Country
Mexico
Facility Name
Site Ref # / Investigator 4073
City
Chihuahua
ZIP/Postal Code
31310
Country
Mexico
Facility Name
Site Ref # / Investigator 4052
City
Oaxaca
Country
Mexico
Facility Name
Site Ref # / Investigator 4053
City
Puebla
ZIP/Postal Code
72570
Country
Mexico

12. IPD Sharing Statement

Links:
URL
http://rxabbvie.com
Description
Related Info

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Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

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