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Directly Observed Therapy in High Risk Populations in Newark, NJ

NCT ID: NCT00285883

Last Updated: 2006-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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

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Directly Observed Therapy HIV Infections

Keywords

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Invirase HIV DOT Treatment Experienced

Interventions

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Invirase

Intervention Type DRUG

Norvir

Intervention Type DRUG

Eligibility Criteria

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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

\-

Exclusion Criteria

1. ALT/AST \> 5X ULN
2. CReatinine \>2.0 -
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Saint Michael's Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Jihad Slim, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Michael's Medical Center

Locations

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Saint Michael's Medical Center

Newark, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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36/03

Identifier Type: -

Identifier Source: org_study_id