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A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Health Manpower, Accidents, Occupational, Zidovudine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Glaxo Wellcome Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002287
Brief Title
A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus
Official Title
A Placebo-Controlled Trial to Evaluate Retrovir in Preventing Infection With the Human Immunodeficiency Virus (HIV) in Health Care Workers After Accidental Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
August 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for health care workers at risk for HIV infection from exposure to HIV-contaminated blood or blood components.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Health Manpower, Accidents, Occupational, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Glaxo Wellcome Inc
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

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A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus

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