A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
This study has been completed.
Sponsor:
Montefiore Medical Center
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
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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: | Endpoint Classification: Efficacy Study 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:
Further study details as provided by Montefiore Medical Center:
Primary Outcome Measures:
- Proportion with virologic suppression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| 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:
-
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.
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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 |
| Health Authority: | United States: Institutional Review Board |
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 September 28, 2016