Back to resultsA Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MEMS cap monitoring
MEMS cap monitoring
MEMS cap monitoring
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV, Adherence, MEMS
Eligibility Criteria
Inclusion Criteria:
- Participation in the prior Kaletra MEMS cap study
Exclusion Criteria:
- Not receiving antiretroviral therapy, refusal to provide informed consent
Sites / Locations
- Montefiore Medical Center
Outcomes
Primary Outcome Measures
Proportion with virologic suppression
Secondary Outcome Measures
Full Information
NCT ID
NCT00785616
First Posted
November 4, 2008
Last Updated
April 25, 2018
Sponsor
Montefiore Medical Center
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00785616
Brief Title
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
Official Title
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, Adherence, MEMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
MEMS cap monitoring
Intervention Description
Electronic monitoring of medication adherence using MEMS caps
Intervention Type
Other
Intervention Name(s)
MEMS cap monitoring
Intervention Description
Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time signature of each bottle opening.
Intervention Type
Other
Intervention Name(s)
MEMS cap monitoring
Intervention Description
Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time/date signature of each bottle opening.
Primary Outcome Measure Information:
Title
Proportion with virologic suppression
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in the prior Kaletra MEMS cap study
Exclusion Criteria:
Not receiving antiretroviral therapy, refusal to provide informed consent
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
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