Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000993
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
1991-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: