We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Drug: Truvada Drug: Raltegravir Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : May 2011
Primary Completion Date : December 2013
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Truvada and Raltegravir
Single arm
Drug: Truvada
Tenofovir 200mg/emtricitabine 300mg once a day
Other Name: Tenofovir 200mg/emtricitabine 300mg
Drug: Raltegravir
Raltegravir 400mg twice a day
Other Name: Isentress

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be at least 18 years of age
  • HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and without any signs or symptoms of acute HIV infection
  • Able to understand and provide consent
  • High-Risk Exposure Characteristic (One or more of the below, unprotected or with failed condom use):

    • Receptive Anal Intercourse
    • Insertive Anal Intercourse
    • Receptive Vaginal Intercourse
    • Insertive Vaginal Intercourse
    • Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source
  • High-Risk Source (One or more of the below):

    • Known HIV positive
    • MSM
    • MSM/W
    • CSW
  • Sexual perpetrator Partner of one of the above
  • Exposure within 72 hours of presentation
  • Not known to be HIV-1 positive
  • No countermanding concomitant medications or allergies

Exclusion Criteria:

  • Patients <18 years of age
  • Unable to understand and provide consent
  • Non-occupational exposure to HIV-1 not recent enough to commence the first dose of study medication within 72 hours from the exposure
  • Known to be HIV positive
  • Any condition which in the opinion of the intake provider will seriously compromise the patient's ability to comply with the protocol, including adherence to nPEP medication
  • Demonstrated HIV-1 positive on rapid testing
  • Unwillingness to commit to barrier-method (male and/or female condom) use until HIV negative status is confirmed 6 months after exposure
  • Unwillingness of breast-feeding women to transition to formula feeding
  • Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures
  • Pregnancy
  • Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine or other therapy for hepatitis B
  • Creatinine clearance less than 30 mL/min as calculated by Cockcroft-Gault formula
  • Unwillingness to participate in study procedures, including Mental Health referral and intervention
  • Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir
  • Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Merck Sharp & Dohme Corp.
Gilead Sciences
Principal Investigator: Karen J Vigil, MD The University of Texas Health Science Center, Houston
More Information

Responsible Party: Karen Vigil, Assistant Professor - Internal Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01214759     History of Changes
Other Study ID Numbers: UT-NPEP
First Posted: October 5, 2010    Key Record Dates
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016
Last Verified: January 2016

Keywords provided by Karen Vigil, The University of Texas Health Science Center, Houston:

Additional relevant MeSH terms:
Raltegravir Potassium
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors