Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

AbbVie (prior sponsor, Abbott)207 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

207

Conditions

Human Immunodeficiency Virus

Interventions

lopinavir/ritonavirDRUG

lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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 (13)

Site Ref # / Investigator 4074

León, Guanajauto, Mexico

Site Ref # / Investigator 4049

Mexico City, Mexico City, Mexico

Site Ref # / Investigator 4050

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Quality of Life

Time frame: Baseline, Week 4, Week 24 and Week 48

CD4

Time frame: Baseline, Week 24 and Week 48

Secondary Outcomes

Adverse Event Monitoring

Time frame: Baseline, Week 4, Week 24 and Week 48

Data from ClinicalTrials.gov

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