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Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Gilead Sciences
Information provided by (Responsible Party):
Karen Vigil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01214759
First received: September 30, 2010
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
HIV
Drug: Truvada
Drug: Raltegravir
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: May 2011
Study Completion Date: August 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214759

Locations
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
Investigators
Principal Investigator: Karen J Vigil, MD The University of Texas Health Science Center, Houston
  More Information

Publications:
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 
Study First Received: September 30, 2010
Results First Received: January 7, 2016
Last Updated: January 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
HIV
prevention
prophylaxis
Raltegravir
Truvada

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Raltegravir Potassium
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

ClinicalTrials.gov processed this record on December 07, 2016