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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002287 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus |
| Official Title ICMJE | A Placebo-Controlled Trial to Evaluate Retrovir in Preventing Infection With the Human Immunodeficiency Virus (HIV) in Health Care Workers After Accidental Exposure |
| 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Placebo Control |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Drug: Zidovudine |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Patients are excluded if there is a prior diagnosis of HIV infection by one of the following criteria:
Prior Medication: Excluded within 4 weeks of study entry:
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:
Active drug or alcohol abuse sufficient in the physician's opinion to prevent compliance with the study regimen. |
| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002287 |
| Responsible Party | |
| Study ID Numbers ICMJE | 014I, 20 |
| Study Sponsor ICMJE | Glaxo Wellcome |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | August 1989 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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