Directly Observed Therapy in High Risk Populations in Newark, NJ
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00285883 |
Recruitment Status
:
Completed
First Posted
: February 2, 2006
Last Update Posted
: February 28, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Directly Observed Therapy HIV Infections | Drug: Invirase Drug: Norvir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Official Title: | Directly Observed Therapy in High Risk Populations in Newark, NJ |
Study Start Date : | April 2004 |
Study Completion Date : | May 2006 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
- ALT/AST > 5X ULN
- CReatinine >2.0 -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285883
United States, New Jersey | |
Saint Michael's Medical Center | |
Newark, New Jersey, United States, 07102 |
Principal Investigator: | Jihad Slim, MD | Saint Michael's Medical Center |
ClinicalTrials.gov Identifier: | NCT00285883 History of Changes |
Other Study ID Numbers: |
36/03 |
First Posted: | February 2, 2006 Key Record Dates |
Last Update Posted: | February 28, 2006 |
Last Verified: | January 2006 |
Keywords provided by Saint Michael's Medical Center:
Invirase HIV DOT Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Saquinavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |