Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122486
Status:
COMPLETED
Last Update Posted:
2006-08-01
First Post:
2005-07-20
Brief Title:
Study of Tenofovir Disoproxil Fumarate TDF for Prevention of HIV
Sponsor:
FHI 360
Organization:
FHI 360
Study Overview
Official Title:
Phase 2 Study of Tenofovir Disoproxil Fumarate TDF for Prevention of HIV
Status:
COMPLETED
Status Verified Date:
2006-07
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 2 study involving tenofovir disoproxil fumarate TDF will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected
Detailed Description:
The protocol describes a randomized fully-masked parallel placebo-controlled study of TDF for pre-exposure prophylaxis of HIV in high-risk women TDF was selected for investigation as prophylaxis against HIV in high-risk women because of its unique pharmacological 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 a therapeutic agent
Participants HIV status is monitored monthly Participants are also monitored for safety using periodic physical examinations serial laboratory tests and adverse event queries Lab tests for kidney and liver function were to be conducted at screening months 1 3 and every 3 months thereafter or at the final visit if early withdrawal To minimize the risk of contracting HIV infection participants are counseled monthly to use male condoms for each act of intercourse Participants converting for antibodies to HIV are counseled and referred to medical services as appropriate for each country
Participants HIV status is monitored monthly Participants are also monitored for safety using periodic physical examinations serial laboratory tests and adverse event queries Lab tests for kidney and liver function were to be conducted at screening months 1 3 and every 3 months thereafter or at the final visit if early withdrawal To minimize the risk of contracting HIV infection participants are counseled monthly to use male condoms for each act of intercourse Participants converting for antibodies to HIV are counseled and referred to medical services as appropriate for each country
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