Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir

Intervention Type DRUG

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

Interventions

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lopinavir/ritonavir

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

Intervention Type DRUG

Other Intervention Names

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ABT-378 Kaletra

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No