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NCT00785616 Clinical Trial

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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00785616
Other study ID # 08-03086E
Secondary ID
Status Completed
Phase Phase 4
First received November 4, 2008
Last updated April 25, 2018
Start date September 2008
Est. completion date October 2009

Study information
Verified date April 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date October 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Participation in the prior Kaletra MEMS cap study

Exclusion Criteria:

- Not receiving antiretroviral therapy, refusal to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• MEMS cap monitoring
Electronic monitoring of medication adherence using MEMS caps
• 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.
• 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.

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (2)
Lead Sponsor Collaborator
Montefiore Medical Center Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion with virologic suppression 24 weeks
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