Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus
Intervention: lopinavir/ritonavir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AbbVie (prior sponsor, Abbott) Official(s) and/or principal investigator(s): Jose Canadas, MD, Study Director, Affiliation: AbbVie
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.
Clinical Details
Official title: Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Quality of LifeCD4
Secondary outcome: Adverse Event Monitoring
Eligibility
Minimum age: 17 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Site Ref # / Investigator 4073, Chihuahua 31310, Mexico
Site Ref # / Investigator 4052, Oaxaca, Mexico
Site Ref # / Investigator 4053, Puebla 72570, Mexico
Site Ref # / Investigator 4049, Mexico City, Distrito Federal 01030, Mexico
Site Ref # / Investigator 4050, Mexico City, Distrito Federal 01120, Mexico
Site Ref # / Investigator 4051, Mexico City, Distrito Federal 09220, Mexico
Site Ref # / Investigator 4056, Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4077, Mexico City, Distrito Federal 10300, 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 97219, Mexico
Additional Information
Starting date: November 2003
Last updated: March 14, 2013
|