Directly Observed Therapy in High Risk Populations in Newark, NJ

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Saint Michael's Medical Center
ClinicalTrials.gov Identifier:
NCT00285883
First received: January 31, 2006
Last updated: February 27, 2006
Last verified: January 2006

January 31, 2006
February 27, 2006
April 2004
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Complete list of historical versions of study NCT00285883 on ClinicalTrials.gov Archive Site
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Directly Observed Therapy in High Risk Populations in Newark, NJ
Directly Observed Therapy in High Risk Populations in Newark, NJ

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

Interventional
Phase 3
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  • Directly Observed Therapy
  • HIV Infections
  • Drug: Invirase
  • Drug: Norvir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2006
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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 -
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00285883
36/03
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Saint Michael's Medical Center
Hoffmann-La Roche
Principal Investigator: Jihad Slim, MD Saint Michael's Medical Center
Saint Michael's Medical Center
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP