- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002287
A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus
A Placebo-Controlled Trial to Evaluate Retrovir in Preventing Infection With the Human Immunodeficiency Virus (HIV) in Health Care Workers After Accidental Exposure
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- Glaxo Wellcome Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- A prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- Other significant, chronic underlying medical illness which, in the physician's judgment, would impair study completion.
- Evidence of compromised bone marrow function (lab results) with a blood transfusion within the last month.
- Liver dysfunction as indicated by lab results.
Patients are excluded if there is a prior diagnosis of HIV infection by one of the following criteria:
- HIV antibody positive by ELISA and Western blot assays or by other certified test method. (Patients who are ELISA positive but Western blot or other confirmatory tests are negative may continue in study).
- HIV antigen positive.
- Clinical symptoms which lead to a diagnosis by a licensed physician of AIDS or AIDS related complex or AIDS-related dementia. Also excluded are individuals who have experienced similar HIV exposure as described in this protocol in the past month and individuals who have previously been enrolled in this study. The purpose of these exclusions is to eliminate possible seroconversion in an individual that could be attributed to HIV exposure other than the single exposure experienced just prior to entry into the study.
Prior Medication:
Excluded within 4 weeks of study entry:
- Any potentially myelosuppressive drug.
- Nephrotoxic agent.
- Other experimental therapy.
Exposure of a health care worker to HIV-contaminated blood or blood component within 5 days prior to beginning therapy, defined as one of the following:
- Penetrating wound from needle recently removed from patient or sample container (e.g., blood bag, blood tube) or from sharp object visibly contaminated with HIV-positive blood or blood component. In the case of needlesticks or cuts with sharp objects, blood or blood component must not have been exposed to the air for more than 1 hour. If actual infusion of blood occurs, the 1-hour time limit does not apply.
- Hypodermic needles should come in contact with the blood and blood component from an HIV source but need not be visibly contaminated with blood to be considered a source of contamination.
- Significant exposure to HIV-positive blood or blood component as the result of splash on abraded skin.
- Significant exposure to HIV-positive blood or blood component as the result of splash on mucous membranes.
- Participant must be able to give informed consent.
Active drug or alcohol abuse sufficient in the physician's opinion to prevent compliance with the study regimen.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- 014I
- 20 (Sophies Minde Ortopedi AS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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