Status:
COMPLETED
Characterization of the Adherence Threshold for HIV Suppression of a Kaletra-based Regimen
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Abbott
Conditions:
HIV Infection
Eligibility:
All Genders
19+ years
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00200369
Start Date
May 1 2004
End Date
March 1 2006
Last Update
November 5 2009
Active Locations (1)
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1
Montefiore Medical Center I.D. Clinic
The Bronx, New York, United States, 10467