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| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | August 25, 2008 | ||||
| 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 NCT00000993 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus | ||||
| Official Title ICMJE | An Open Protocol for the Use of Zidovudine for Prophylactic Treatment of Individuals After Accidental Massive Exposure to the Human Immunodeficiency Virus (HIV) | ||||
| Brief Summary | To prevent individuals who have had a massive accidental exposure to HIV from becoming infected with HIV and possibly developing AIDS, by treating them with zidovudine (AZT). Although the number of persons who have been (or will be) exposed to a high concentration of HIV is quite small, these persons have a high risk of becoming infected and treatments are needed to prevent infection after such an exposure. In animal studies, AZT has prevented the development of infections after exposure of the animals to a retrovirus (the HIV is a retrovirus). In patients with AIDS, AZT has been effective in delaying the progression of the disease. For these reasons a trial of AZT is indicated. |
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| Detailed Description | Although the number of persons who have been (or will be) exposed to a high concentration of HIV is quite small, these persons have a high risk of becoming infected and treatments are needed to prevent infection after such an exposure. In animal studies, AZT has prevented the development of infections after exposure of the animals to a retrovirus (the HIV is a retrovirus). In patients with AIDS, AZT has been effective in delaying the progression of the disease. For these reasons a trial of AZT is indicated. Persons accepted into the study will take AZT capsules every 4 hours (6 times daily) for 42 days. Treatment with AZT should start as soon as possible, but no later than 5 days, after exposure to the HIV. Blood and urine samples for various studies will be taken at intervals during the 42-day treatment period, and blood samples will be taken every 3 months for 1 year and every 6 months for 2 years and tested for signs of HIV infection (HIV antibody determinations). |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Open Label | ||||
| 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 | Inclusion Criteria Participant must be HIV-negative at entry and source must be HIV-positive. The source should be documented to be infected with HIV by one of the following criteria:
Exclusion Criteria Prior Medication: Excluded within 4 weeks of study entry:
Prior Treatment: Excluded within 1 month of study entry:
Patients may not have any of the following:
When possible, no other concomitant medication will be administered during the treatment period. Prior diagnosis of HIV infection by one of the following criteria:
Active drug or alcohol abuse sufficient in the investigators' opinion to prevent compliance with the study regimen. |
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| 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 | NCT00000993 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NS 402 | ||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | April 1991 | ||||
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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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