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A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

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ClinicalTrials.gov Identifier: NCT00785616
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : July 23, 2010
Sponsor:
Collaborator:
Abbott
Information provided by:
Montefiore Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence, conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of MEMS cap adherence measurements over time.

Condition or disease Intervention/treatment Phase
HIV Infection Other: MEMS cap monitoring Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Other: MEMS cap monitoring
    Electronic monitoring of medication adherence using MEMS caps
    Other: MEMS cap monitoring
    Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time signature of each bottle opening.
    Other: MEMS cap monitoring
    Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time/date signature of each bottle opening.

Outcome Measures
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Primary Outcome Measures :
  1. Proportion with virologic suppression [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the prior Kaletra MEMS cap study

Exclusion Criteria:

  • Not receiving antiretroviral therapy, refusal to provide informed consent
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785616


Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Abbott
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Roxann Stubbs, NP, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00785616     History of Changes
Other Study ID Numbers: 08-03086E
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010

Keywords provided by Montefiore Medical Center:
HIV
Adherence
MEMS

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