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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785616
First Posted: November 5, 2008
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by:
Montefiore Medical Center
  Purpose
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 Intervention Phase
HIV Infection Other: MEMS cap monitoring Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

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

Estimated Enrollment: 55
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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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
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

Responsible Party: Roxann Stubbs, NP, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00785616     History of Changes
Other Study ID Numbers: 08-03086E
First Submitted: November 4, 2008
First Posted: November 5, 2008
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