Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078182
Status:
WITHDRAWN
Last Update Posted:
2016-12-14
First Post:
2004-02-19
Brief Title:
Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Study of Daily Oral Tenofovir Tenofovir Disoproxil Fumarate to Prevent HIV-1 Infection Among Sex Workers in Cambodia
Status:
WITHDRAWN
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tenofovir disoproxil fumarate also known as tenofovir DF or Viread is used with other anti-HIV drugs to treat HIV infection Taking tenofovir DF every day may also prevent HIV infection This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection Participants in the study will be sex workers in Phnom Penh Cambodia
Detailed Description:
Cambodia has one of the highest rates of HIV infection in Southeast Asia At the end of 2002 HIV infection rates among Cambodian sex workers ranged from 148 to 288 Tenofovir DF is a nucleotide reverse transcriptase inhibitor NRTI that was licensed for the treatment of HIV-1 infection by the United States Food and Drug Administration FDA in October 2001 This randomized clinical trial will determine if a daily oral 300 mg dose of tenofovir DF is safe and effective in preventing HIV-1 infection This is a collaborative study between the University of California San Francisco the University of New South Wales and the Ministry of Health of Cambodia
Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months Participants will be evaluated for rates of HIV infection adherence to the drug regimen and changes in risk behaviors All participants will be monitored throughout the trial for side effects and toxicity Participants will be involved in the study for 14 months
Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months Participants will be evaluated for rates of HIV infection adherence to the drug regimen and changes in risk behaviors All participants will be monitored throughout the trial for side effects and toxicity Participants will be involved in the study for 14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None