Directly Observed Therapy in High Risk Populations in Newark, NJ
Primary Purpose
Directly Observed Therapy, HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Invirase
Norvir
Sponsored by
About this trial
This is an interventional trial for Directly Observed Therapy focused on measuring Invirase, HIV, DOT, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: 1. Men and Women > 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count <350 and or history of opportunistic infection 3. HIV PCR >55000 and >55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian - Exclusion Criteria: ALT/AST > 5X ULN CReatinine >2.0 -
Sites / Locations
- Saint Michael's Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00285883
First Posted
January 31, 2006
Last Updated
February 27, 2006
Sponsor
Saint Michael's Medical Center
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00285883
Brief Title
Directly Observed Therapy in High Risk Populations in Newark, NJ
Official Title
Directly Observed Therapy in High Risk Populations in Newark, NJ
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Saint Michael's Medical Center
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's 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 Michael's 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 therapy.Each patient will be placed on Fortovase/Ritonavir (1600mg/100mg)QD 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 copies/mL at week 24 on two separate occasions at least 14 days apart
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Directly Observed Therapy, HIV Infections
Keywords
Invirase, HIV, DOT, Treatment Experienced
7. Study Design
Study Phase
Phase 3
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Invirase
Intervention Type
Drug
Intervention Name(s)
Norvir
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Men and Women > 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count <350 and or history of opportunistic infection 3. HIV PCR >55000 and >55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian
-
Exclusion Criteria:
ALT/AST > 5X ULN
CReatinine >2.0 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihad Slim, MD
Organizational Affiliation
Saint Michael's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Directly Observed Therapy in High Risk Populations in Newark, NJ
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