Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122512
Status:
TERMINATED
Last Update Posted:
2006-02-10
First Post:
2005-07-19
Brief Title:
Study of Tenofovir Disoproxil Fumarate TDF for Prevention of HIV
Sponsor:
FHI 360
Organization:
FHI 360
Study Overview
Official Title:
Phase 2a Study of Tenofovir Disoproxil Fumarate TDF for Prevention of HIV - An Extended Safety Evaluation
Status:
TERMINATED
Status Verified Date:
2006-02
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:
This Phase 2a study involving Tenofovir Disoproxil Fumarate TDF will provide extended safety data for high-risk men Secondarily the study will assess the feasibility of conducting the trial and evaluate the preliminary effectiveness of TDF 300 mg as an HIV prevention method when taken once a day
Detailed Description:
TDF has been selected for investigation as prophylaxis against HIV in high-risk men because of its unique pharmacologic profile In addition to the convenience of being a once daily single tablet TDFs safety profile is comparable to placebo among HIV infected persons it has striking anti-HIV potency and it has low potential for selection of resistant viruses TDF is cleared from the body by the kidneys and is not metabolized by the liver Therefore TDF has limited potential to have pharmacokinetic interactions with other hepatically metabolized drugs Each of these properties is necessary given the realities of the intended target populations Moreover initial prevention studies in simian models have provided encouraging results Finally the drugs sponsor is supportive of investigating the potential use of TDF as a preventive as well as therapeutic agent will provide TDF for the study and is willing to make a good faith effort to make TDF available for public health use should it prove to be effective for HIV prevention
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