Status:
COMPLETED
Directly Observed Therapy in High Risk Populations in Newark, NJ
Lead Sponsor:
Saint Michael's Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Directly Observed Therapy
HIV Infections
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- ALT/AST \> 5X ULN
- CReatinine \>2.0 -
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00285883
Start Date
April 1 2004
End Date
May 1 2006
Last Update
February 28 2006
Active Locations (1)
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1
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102