Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285883
Status:
COMPLETED
Last Update Posted:
2006-02-28
First Post:
2006-01-31
Brief Title:
Directly Observed Therapy in High Risk Populations in Newark NJ
Sponsor:
Saint Michaels Medical Center
Organization:
Saint Michaels Medical Center
Study Overview
Official Title:
Directly Observed Therapy in High Risk Populations in Newark NJ
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michaels Medical Center and be given Directly observed therapy
Detailed Description:
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michaels Medical Center Consent will be obtained their regimens will be switched to QD based on previous therapies and resistance patterns if available Patients will be placed on direct observed therapyEach patient will be placed on FortovaseRitonavir 1600mg100mgQD plus two or three NRTIs based on a phenotypic baseline testing to a protease inhibitor Patients will visit the office at baseline weeks 1 4 8 12 16 24 32 40 and 48 Patients will also be visited daily by the social worker or designee to observe patients taking their antiretroviral therapy for 6 months After six months of direct observed therapy patients will be given a diary card to record administration of medications and the social worker or designee will visit the home twice weekly If the patient experiences a change in therapy secondary to virologic failure the patient will return to baseline visit for the new once a day regimen Virologic failure will be defined as 5 log drop between each visit or 400 copiesmL at week 24 on two separate occasions at least 14 days apart
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None