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Characterization of the Adherence Threshold for HIV Suppression of a Kaletra-based Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200369
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 5, 2009
Information provided by:
Montefiore Medical Center

Brief Summary:
The hypothesis of this study is that the level of adherence necessary to achieve HIV virologic suppression with a ritonavir boosted protease inhibitor regimen (i.e. lopinavir/ritonavir) is less than the 95% rate observed in the published literature with unboosted regimens.

Condition or disease Intervention/treatment
HIV Infection Device: MEMS cap

Detailed Description:

The existing dogma is that patients receiving highly active antiretroviral therapy (HAART) to treat their HIV infection must take at least 95% of prescribed doses in order to maintain full suppression of viral replication. This belief is largely based on a single study that was performed between 1997 and 1999 (Ann Int Med 2000;133:21-30). The vast majority of patients in this study were receiving regimens based on either indinavir, nelfinavir, ritonavir, or saquinavir. All of these agents have relatively short half-lives, and therefore must be taken on time two or three times per day. Newer medications such as lopinavir/ritonavir (Kaletra) feature much more favorable pharmacokinetic profiles. On the basis of improved pharmacokinetics, there is reason to believe that regimens built around such agents may be more forgiving of missed medication doses.

This study aims to enroll 90 patients from the MMC I.D. Clinic who are either receiving or are about to receive Kaletra. Patients who agree to participate will be furnished with a MEMS cap, a bottle cap that electronically records each time that the bottle is opened and stores the data for computer download, and will undergo electronic monitoring of their Kaletra adherence for a period of siz months. Adherence data will not be reviewed during the study, but at study end (and at interim time points), the investigators will analyze the MEMS cap data from patients who have completed the study in order to determine the threshold value of adherence necessary to achieve satisfactory rates (i.e. 70-80%) of complete virologic suppression.

An additional aim of the study is to collect specimens from patients receiving Kaletra based regimens who experience virologic failure and to archive them for possible studies of genotypic and phenotypic resistance in the future.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Adherence Threshold for HIV Suppression of a Kaletra-based Regimen
Study Start Date : May 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic with eligibility criteria as listed below.

Inclusion Criteria:

  • HIV infection
  • Receiving twice daily Kaletra at an FDA approved dosage
  • Age>18 years
  • CD4 and viral load available within seven day of enrollment
  • Patient willingness to accept MEMS cap monitoring
  • HIV genotype within 60 days of enrollment for patients with viral load>1000
  • Patient willingness to grant informed consent and complete five study visits

Exclusion Criteria:

  • Provider or patient deem it unlikely that Kaletra therapy will continue for the ensuing 24 weeks
  • Prescription of any medication that is contraindicated for Kaletra recipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200369

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United States, New York
Montefiore Medical Center I.D. Clinic
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
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Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00200369    
Other Study ID Numbers: 03-10-268
Abbott Laboratories #378-03-71
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 5, 2009
Last Verified: November 2009
Keywords provided by Montefiore Medical Center:
Antiretroviral therapy
Protease inhibitor
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases