Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

Phase 4

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Drug: lopinavir/ritonavir

• Registration Number: NCT00648999
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	lopinavir/ritonavir	-
1	lopinavir/ritonavir	-

Primary Outcome Measures

Name	Time	Method
Quality of Life	Baseline, Week 4, Week 24 and Week 48
CD4	Baseline, Week 24 and Week 48

Secondary Outcome Measures

Name	Time	Method
Adverse Event Monitoring	Baseline, Week 4, Week 24 and Week 48

Trial Locations

Locations (13)

Site Ref # / Investigator 4049; 🇲🇽 Mexico City, Distrito Federal, Mexico

Site Ref # / Investigator 4052; 🇲🇽 Oaxaca, Mexico

Site Ref # / Investigator 4055; 🇲🇽 Culiacan, Sinaloa, Mexico

Site Ref # / Investigator 4051; 🇲🇽 Mexico City, Distrito Federal, Mexico

Site Ref # / Investigator 4077; 🇲🇽 Mexico City, Distrito Federal, Mexico

Site Ref # / Investigator 4074; 🇲🇽 Leon, Guanajauto, Mexico

Site Ref # / Investigator 4072; 🇲🇽 Tepic, Nayarit, Mexico

Site Ref # / Investigator 4054; 🇲🇽 Morelia, Michoacan, Mexico

Site Ref # / Investigator 4053; 🇲🇽 Puebla, Mexico

Site Ref # / Investigator 4073; 🇲🇽 Chihuahua, Mexico

Site Ref # / Investigator 4050; 🇲🇽 Mexico City, Distrito Federal, Mexico

Site Ref # / Investigator 4056; 🇲🇽 Mexico City, Distrito Federal, Mexico

Site Ref # / Investigator 4075; 🇲🇽 Merida, Yucatan, Mexico