HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health Identifier:
First received: January 7, 2008
Last updated: August 10, 2015
Last verified: August 2015
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Condition Intervention Phase
HIV Infections
Drug: TRUVADA + raltegravir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1

Resource links provided by NLM:

Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • Medication Regimen Completion Rates [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Pill counts performed at 14 and 28 days

  • Number of HIV-1 Infected Participants [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected

Enrollment: 100
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
TRUVADA + raltegravir
Drug: TRUVADA + raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Other Names:
  • tenofovir DF
  • emtricitabine

Detailed Description:
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
  • Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
  • Able to understand the study procedures and willing to sign informed consent

Exclusion Criteria:

  • 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 therapy for hepatitis B.
  • Creatinine clearance less than 50 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
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Please refer to this study by its identifier: NCT00594646

United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Fenway Community Health
Merck Sharp & Dohme Corp.
Principal Investigator: Kenneth H Mayer, MD Fenway Community Health
  More Information

Additional Information:
Responsible Party: Kenneth H. Mayer, MD, Medical Director, The Fenway Institute, Fenway Community Health Identifier: NCT00594646     History of Changes
Other Study ID Numbers: MK PEP 2007
Study First Received: January 7, 2008
Results First Received: August 10, 2015
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Fenway Community Health:
HIV Prevention
Non-occupational post-exposure prophylaxis
HIV seronegativity

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on November 25, 2015