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

NCT ID: NCT00785616

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MEMS cap monitoring

Electronic monitoring of medication adherence using MEMS caps

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participation in the prior Kaletra MEMS cap study

Exclusion Criteria

* Not receiving antiretroviral therapy, refusal to provide informed consent
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Shuter

Prof. Dept Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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08-03086E

Identifier Type: -

Identifier Source: org_study_id

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