A Phase 3 interventional study of Invirase and Norvir in Directly Observed Therapy and HIV Infections, sponsored by Saint Michael's Medical Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-02-28.
Sponsored by Saint Michael's Medical Center · Phase 3 and Interventional
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.
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
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Saint Michael's Medical Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Saint Michael's Medical Center