Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT01214759
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV)
Status:
COMPLETED
Status Verified Date:
2016-01
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 study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.
Detailed Description:
Non-Occupational Post-Exposure Prophylaxis (nPEP) after sexual exposure to HIV is recommended by the Centers for Disease Control (CDC). Although no efficacy data exist for Post-Exposure Prophylaxis (PEP) after sexual exposure, PEP has been shown to reduce HIV transmission in other exposure situations such as occupational exposures and mother-to-child transmission. The role in nPEP of the newer agents approved for the treatment of HIV infection remains unknown. The anti-HIV drug raltegravir works early in the life cycle of the virus, before it integrates with human DNA. It has few side effects and drug interactions what makes it an ideal drug for an nPEP regimen.
We aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.
We aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.
Study Oversight
Has Oversight DMC:
True
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?: