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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 Life

CD4

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

Page last updated: August 23, 2015

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