Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
|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)|
- Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.
- Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.
- Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||August 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Truvada and Raltegravir
Tenofovir 200mg/emtricitabine 300mg once a day
Other Name: Tenofovir 200mg/emtricitabine 300mgDrug: Raltegravir
Raltegravir 400mg twice a day
Other Name: Isentress
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214759
|United States, Texas|
|The University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Karen J Vigil, MD||The University of Texas Health Science Center, Houston|