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:	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 ]


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:

Electronic monitoring of medication adherence using MEMS caps

Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time signature of each bottle opening.

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by Montefiore Medical Center:


HIV Adherence MEMS

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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