NCT00285883

Directly Observed Therapy in High Risk Populations in Newark, NJ

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Saint Michael's Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Directly Observed Therapy
• HIV Infections

Interventions

Type	Name	Description
DRUG	Invirase
DRUG	Norvir

Timeline

• Start date: 2004-04-01
• Completion: 2006-05-01
• First posted: 2006-02-02
• Last updated: 2006-02-28

Locations

1 site across 1 country: United States