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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002287
• Other study ID #: 014I
• Secondary ID: 20
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
United States	Glaxo Wellcome Inc	Research Triangle Park	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,