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

This study has been terminated.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00234962

First received: September 13, 2005

Last updated: November 19, 2008

Last verified: November 2008

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: Lopinavir/Ritonavir	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Antiviral efficacy by HIV RNA

Secondary Outcome Measures:

Treatment related discontinuations, predictors of adherence


Estimated Enrollment:	200
Study Start Date:	August 2002
Study Completion Date:	February 2007

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234962

Locations


United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Global Medical Information	Abbott

More Information


ClinicalTrials.gov Identifier:	NCT00234962 History of Changes
Other Study ID Numbers:	PUER-01-001
Study First Received:	September 13, 2005
Last Updated:	November 19, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:


HIV Infection HAART Lopinavir	Ritonavir Treatment Experienced Treatment Naive

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

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