HIV Infections Clinical Trial
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)
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.
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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Masking: Open Label, Primary Purpose: Prevention
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