Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
1 other identifier
interventional
207
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2003
Typical duration for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedMarch 15, 2013
January 1, 2013
3.1 years
March 28, 2008
March 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of Life
Baseline, Week 4, Week 24 and Week 48
CD4
Baseline, Week 24 and Week 48
Secondary Outcomes (1)
Adverse Event Monitoring
Baseline, Week 4, Week 24 and Week 48
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Site Ref # / Investigator 4074
León, Guanajauto, Mexico
Site Ref # / Investigator 4049
Mexico City, Mexico City, 01030, Mexico
Site Ref # / Investigator 4050
Mexico City, Mexico City, 01120, Mexico
Site Ref # / Investigator 4051
Mexico City, Mexico City, 09220, Mexico
Site Ref # / Investigator 4077
Mexico City, Mexico City, 10300, Mexico
Site Ref # / Investigator 4056
Mexico City, Mexico City, Mexico
Site Ref # / Investigator 4054
Morelia, Michoacán, Mexico
Site Ref # / Investigator 4072
Tepic, Nayarit, Mexico
Site Ref # / Investigator 4052
Oaxaca City, Oaxaca, Mexico
Site Ref # / Investigator 4053
Puebla City, Puebla, 72570, Mexico
Site Ref # / Investigator 4055
Culiacán, Sinaloa, Mexico
Site Ref # / Investigator 4075
Mérida, Yucatán, 97219, Mexico
Site Ref # / Investigator 4073
Chihuahua City, 31310, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jose Canadas, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
November 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
March 15, 2013
Record last verified: 2013-01