Completed

Retrovir Safety and Effectiveness in HIV Prevention for Health Care Workers

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What is being tested

Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on evaluating the safety and effectiveness of a drug called Retrovir, also known as AZT. The aim is to understand if Retrovir can help prevent HIV infection in healthcare workers who are at risk due to accidental exposure to HIV-contaminated blood or blood components. The importance of this study lies in its potential to provide a protective measure for healthcare workers who face such risks in their professional environment.

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Glaxo Wellcome Inc

Research Triangle Park, United StatesOpen Glaxo Wellcome Inc in Google Maps
CompletedOne Study Center