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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000993 |
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.
Condition | Intervention |
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HIV Infections |
Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Prevention, Open Label |
Official Title: | An Open Protocol for the Use of Zidovudine for Prophylactic Treatment of Individuals After Accidental Massive Exposure to the Human Immunodeficiency Virus (HIV) |
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).
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Study ID Numbers: | NS 402 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000993 |
Health Authority: | United States: Federal Government |
HIV-1 Drug Evaluation Accidents |
Acquired Immunodeficiency Syndrome AIDS Serodiagnosis Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |