Directly Observed Therapy in High Risk Populations in Newark, NJ

HIV Infections Clinical Trial

Official title:

Directly Observed Therapy in High Risk Populations in Newark, NJ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285883
• Other study ID #: 36/03
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2006
• Last updated: February 27, 2006
• Start date: April 2004
• Est. completion date: May 2006

Study information

• Verified date: January 2006
• Source: Saint Michael's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

1. ALT/AST > 5X ULN

2. CReatinine >2.0 -

Study Design

N/A

Related Conditions & MeSH terms

• Directly Observed Therapy
• HIV Infections

Intervention

Drug:
• Invirase

• Norvir

Locations

Country	Name	City	State
United States	Saint Michael's Medical Center	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Saint Michael's Medical Center	Hoffmann-La Roche

Country where clinical trial is conducted

United States,