Directly Observed Therapy in High Risk Populations in Newark, NJ

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Michael's Medical Center
• Collaborator: Hoffmann-La Roche
• Treatments: Saquinavir

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

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Exclusion Criteria:

1. ALT/AST > 5X ULN

2. CReatinine >2.0 -