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

This study is ongoing, but not recruiting participants.
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: July 18, 2013
Last verified: July 2013
  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: Tenofovir/emtricitabine and 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:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Truvada and Raltegravir
Single arm
Drug: Tenofovir/emtricitabine and raltegravir
Tenofovir 200mg/emtricitabine 300mg once a day and Raltegravir 400mg twice a day
Other Names:
  • Truvada (Tenofovir 200mg/emtricitabine 300mg)
  • Isentress (Raltegravir 400mg)

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
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
Last Updated: July 18, 2013
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014