A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus
|Study Design:||Masking: Open Label
Primary Purpose: Prevention
|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)|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000993
|United States, North Carolina|
|Glaxo Wellcome Inc|
|Research Triangle Park, North Carolina, United States, 27709|
|Study Chair:||Pettinelli C|