Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

AbbVie

Status and phase: Completed; Phase 4

Conditions: Human Immunodeficiency Virus

Treatments: Drug: lopinavir/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00648999

MEXI-P01-02

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: lopinavir/ritonavir

2

Active Comparator group

Treatment:

Drug: lopinavir/ritonavir