Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lopinavir/Ritonavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is documented HIV positive
* Subject is greater than or equal to 18 years of age.
* Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
* Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
* Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
* Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin \>8.0 g/dL; Absolute neutrophil count \>750 cells/mL; Platelet count \>20,000/mL; ALT or AST \<3 x Upper Limit of Normal (ULN); Creatinine \<1.5 x ULN; Triglycerides \<750 mg/dL.
* Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.