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
  Purpose

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.


Condition Intervention Phase
Directly Observed Therapy
HIV Infections
Drug: Invirase
Drug: Norvir
Phase 3

Study Type: Interventional
Official Title: Directly Observed Therapy in High Risk Populations in Newark, NJ

Resource links provided by NLM:


Further study details as provided by Saint Michael's Medical Center:

Estimated Enrollment: 30
Study Start Date: April 2004
Estimated Study Completion Date: May 2006
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285883

Locations
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Saint Michael's Medical Center
Hoffmann-La Roche
Investigators
Principal Investigator: Jihad Slim, MD Saint Michael's Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285883     History of Changes
Other Study ID Numbers: 36/03
Study First Received: January 31, 2006
Last Updated: February 27, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Michael's Medical Center:
Invirase
HIV
DOT
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Saquinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014