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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

November 4, 2008
July 22, 2010
September 2008
August 2009   (final data collection date for primary outcome measure)
Proportion with virologic suppression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00785616 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
October 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participation in the prior Kaletra MEMS cap study

Exclusion Criteria:

  • Not receiving antiretroviral therapy, refusal to provide informed consent
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00785616
08-03086E
No
Roxann Stubbs, NP, Abbott Laboratories
Montefiore Medical Center
Abbott
Not Provided
Montefiore Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP