Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
This study has been terminated.
Information provided by:
First received: September 13, 2005
Last updated: November 19, 2008
Last verified: November 2008
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Antiviral efficacy by HIV RNA
Secondary Outcome Measures:
- Treatment related discontinuations, predictors of adherence
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234962
|Global Medical Information - Abbott
|North Chicago, Illinois, United States, 60064 |
||Global Medical Information
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||November 19, 2008
||United States: Food and Drug Administration
Keywords provided by Abbott:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action