Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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)|
- To determine the efficacy of the antiretroviral drugs being studies in this study to prevent the transmission of HIV infection to HIV negative people sexually exposed to HIV. [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine if the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV negative people who have been exposed to HIV.
- To determine the clinical or laboratory abnormalities secondary to the 28-day exposure to the antiretroviral drugs being explore in this study to prevent the transmission of HIV infection. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To determine the tolerability and capability to complete the 28-day course of the antiretroviral drugs being explore in this study to prevent the transmission of HIV infection. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Truvada and Raltegravir
Drug: Tenofovir/emtricitabine and raltegravir
Tenofovir 200mg/emtricitabine 300mg once a day and Raltegravir 400mg twice a day
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.
|Contact: Karen J Vigil, MD||713-500-6703||Karen.J.Vigil@uth.tmc.edu|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Karen J Vigil, MD 713-500-6703 Karen.J.Vigil@uth.tmc.edu|
|Principal Investigator: Karen J Vigil, MD|
|Principal Investigator:||Karen J Vigil, MD||The University of Texas Health Science Center, Houston|