Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01214759|
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Truvada Drug: Raltegravir||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||May 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||August 2015|
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
- Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months [ Time Frame: 6 months ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|