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

Primary Purpose

HIV Infection

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV Infection, HAART, Lopinavir, Ritonavir, Treatment Experienced, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Exclusion Criteria: -

Sites / Locations

  • Global Medical Information - Abbott

Outcomes

Primary Outcome Measures

Antiviral efficacy by HIV RNA

Secondary Outcome Measures

Treatment related discontinuations, predictors of adherence

Full Information

First Posted
September 13, 2005
Last Updated
November 19, 2008
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00234962
Brief Title
Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
Official Title
Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Terminated
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV Infection, HAART, Lopinavir, Ritonavir, Treatment Experienced, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Primary Outcome Measure Information:
Title
Antiviral efficacy by HIV RNA
Secondary Outcome Measure Information:
Title
Treatment related discontinuations, predictors of adherence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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