Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

Human Immunodeficiency Virus Clinical Trial

Official title:

Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648999
• Other study ID #: MEXI-P01-02
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: March 14, 2013
• Start date: November 2003
• Est. completion date: December 2006

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• lopinavir/ritonavir
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment

Locations

Country	Name	City	State
Mexico	Site Ref # / Investigator 4073	Chihuahua
Mexico	Site Ref # / Investigator 4055	Culiacan	Sinaloa
Mexico	Site Ref # / Investigator 4074	Leon	Guanajauto
Mexico	Site Ref # / Investigator 4075	Merida	Yucatan
Mexico	Site Ref # / Investigator 4049	Mexico City	Distrito Federal
Mexico	Site Ref # / Investigator 4050	Mexico City	Distrito Federal
Mexico	Site Ref # / Investigator 4051	Mexico City	Distrito Federal
Mexico	Site Ref # / Investigator 4056	Mexico City	Distrito Federal
Mexico	Site Ref # / Investigator 4077	Mexico City	Distrito Federal
Mexico	Site Ref # / Investigator 4054	Morelia	Michoacan
Mexico	Site Ref # / Investigator 4052	Oaxaca
Mexico	Site Ref # / Investigator 4053	Puebla
Mexico	Site Ref # / Investigator 4072	Tepic	Nayarit

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		Baseline, Week 4, Week 24 and Week 48	No
Primary	CD4		Baseline, Week 24 and Week 48	Yes
Secondary	Adverse Event Monitoring		Baseline, Week 4, Week 24 and Week 48	Yes

External Links

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