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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:
Collaborator:
Abbott
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00785616
First received: November 4, 2008
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Proportion with virologic suppression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785616

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Abbott
  More Information

No publications provided

Responsible Party: Roxann Stubbs, NP, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00785616     History of Changes
Other Study ID Numbers: 08-03086E
Study First Received: November 4, 2008
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
HIV
Adherence
MEMS

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013